Community Health Plan of Washington Medicare Advantage Plans Community Health Plan of Washington Medicare Advantage Plans

The Drug Recall Report is for prescription drugs that are have recently been issued recalls by the U.S. Food and Drug Administration (FDA). Here’s what you should do if your prescription medications are recalled:  

  • Do not continue to use any recalled prescription medicine
  • Contact your provider or pharmacist if you have experienced any reactions.
  • Check your prescription label for the drug lot number and the expiration date to see if any of your medication is affected by the recall.
  • If you have the medication, contact the pharmacy that you received it from. Any adverse actions or events from the use of prescription drugs should be reported to FDA here or calling 1-800-FDA-0178.

Stay up to date with current recall notices by visiting the FDA website.

LISINOPRIL 10 MG

On 11/20/2024 Legacy Pharmace recalled LISINOPRIL 10 MG due to Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISINOPRIL 10 MG
NDC Number: 68645061090
Lot Number(s): 241103
Expiration Date(s): 5/31/2026

What you should do:

  • Do not continue to use LISINOPRIL 10 MG if it has been recalled
  • Check your prescription label to see if you have any LISINOPRIL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting https://www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

DULOXETINE HCL 20 MG

On 10/23/2024, Breckenridge recalled DULOXETINE HCL 20 MG due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. The U.S. Food and Drug Administration (FDA) has issued a
Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DULOXETINE HCL 20 MG
NDC Number: 51991074605
Lot Number(s): 220128
Expiration Date(s): 12/2024

What you should do:

  • Do not continue to use DULOXETINE HCL 20 MG if it has been recalled
  • Check your prescription label to see if you have any DULOXETINE HCL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

MYCOPHENOLIC ACID 360 MG

On 10/02/204, Ascend Laboratories recalled MYCOPHENOLIC ACID 360 MG due to failed dissolution specifications. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: MYCOPHENOLIC ACID 360 MG
NDC Number: 67877042712
Lot Number(s): 22123437, 22123438, 22123535, 22123536, 22123537, 22123538, 22123646, 22123647, 23120529, 23120530, 23120703, 23120705, 23121429, 23121726, 23122049, 23122097, 23121984, 23121985, 23121986, 23122325, 23122329, 23122330, 23122331, 23122776, 23122852, 23122853, 23123154, 23123155 and 23123458.
Expiration Date(s): 09/30/2024, 10/31/24, 1/31/25, 2/28/25, 4/30/25, 5/31/25, 6/30/26, 8/31/26 and 9/30/26

What you should do:

  • Do not continue to use MYCOPHENOLIC ACID 360 MG if it has been recalled
  • Check your prescription label to see if you have any MYCOPHENOLIC ACID in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

IBUPROFEN 400 MG

On 09/04/2024, Dr. Ready’s recalled IBUPROFEN 400 MG due to Failed 
impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: IBUPROFEN 400 MG
NDC Number: 55111068201 and 55111068205
Lot Number(s): C2207529, C2210993, C2207530, C2210992, C2210994, C2213304 and C2213305
Expiration Date(s): 5/31/2026, 9/30/2026, 5/31/2026, 9/30/2026 AND 11/30/2026

What you should do:

  • Do not continue to use IBUPROFEN 400 MG if it has been recalled
  • Check your prescription label to see if you have any IBU in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

IBUPROFEN 600 MG

On 09/04/2024, Dr. Ready’s recalled IBUPROFEN 600 MG due to Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. The U.S. Food and Drug Administration
(FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: IBUPROFEN 600 MG
NDC Number: 55111068301 AND 55111068305
Lot Number(s): C2207527, C2210864, C2213018, C2207528, C2210860, C2213016, C2213017, C2301852, C2302056 AND C230257
Expiration Date(s): 5/31/2026, 9/30/2026, 11/30/2026, 5/31/2026, 9/30/2026,11/30/2026 AND 1/31/2024

What you should do:

  • Do not continue to use IBUPROFEN 600 MG if it has been recalled
  • Check your prescription label to see if you have any IBU in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

CLONAZEPAM 0.125 MG ODT

On 08/07/2024, Endo Pharma recalled CLONAZEPAM 0.125 MG ODT due to label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CLONAZEPAM 0.125 MG ODT
NDC Number: 49884030602
Lot Number(s): 550147301
Expiration Date(s): 08/31/2026

What you should do:

  • Do not continue to use CLONAZEPAM 0.125 MG if it has been recalled
  • Check your prescription label to see if you have any CLONAZEPAM in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

POTASSIUM CHLORIDE 10 MEQ

On 08/07/2024, Amerisource Health Services recalled POTASSIUM CHLORIDE 10 MEQ due to failed dissolution specifications. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.
More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: POTASSIUM CHLORIDE 10 MEQ
NDC Number: 68001039603, 68001039600
Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:

  • Do not continue to use POTASSIUM CHLORIDE 10 MEQ if it has been recalled
  • Check your prescription label to see if you have any POTASSIUM CHLORIDE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

PRAVASTATIN SODIUM 80 MG

PRAVASTATIN SODIUM 80 MG

On 07/24/2024, Glemark Pharma recalled PRAVASTATIN SODIUM 80 MG due to Failed Dissolution Specifications: results below specifications. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAVASTATIN SODIUM 80 MG
NDC Number: 68462019890
Lot Number(s): 17211249, 17211264, 17211266,17211286, 17211525, 17211535, 17211549, 17211787, 17211801, 17212041, 17212088, 17212106, 17212346, 17212345, 17220053, 17220054, 17220055, 17220309, 17220310, 17211290
Expiration Date(s): 6/30/2024, 7/31/2024, 8/31/2024, 9/30/2024, 10/31/2024, 12/31/2024 and 1/31/2025

What you should do:

  • Do not continue to use PRAVASTATIN SODIUM 80 MG if it has been recalled
  • Check your prescription label to see if you have any PRAVASTATIN SODIUM in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

FLUDROCORTISONE ACETATE 0.1 MG

FLUDROCORTISONE ACETATE 0.1 MG

On 07/24/2024, Teva Pharma recalled FLUDROCORTISONE ACETATE 0.1 MG due to failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: FLUDROCORTISONE ACETATE 0.1 MG
NDC Number: 00555099702
Lot Number(s): CNSDH, CNWVM, CNWWH, CNXKW, CNXKY, CNXMB, CNXMH, CPBTP and CPBTV
Expiration Date(s): 6/30/2024, 7/31/2024, 9/30/2024 and 11/30/2024

What you should do:

  • Do not continue to use FLUDROCORTISONE ACETATE 0.1 MG if it has been recalled
  • Check your prescription label to see if you have any FLUDROCORTISONE ACETATE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

POTASSIUM CHLORIDE 10 MEQ (NDC#68462035701)

POTASSIUM CHLORIDE 10 MEQ

On 07/24/2024, Glenmark Pharmaceutical recalled POTASSIUM CHLORIDE 10 MEQ due to failed dissolution specifications. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: POTASSIUM CHLORIDE 10 MEQ
NDC Number: 68462035701
Lot Number(s): 17221446, 17221445, 17221393, 17221403, 17221405, 17221503, 17221508, 17221567, 17221566, 17221719, 17221731, 17221891, 17221892, 17221900, 17221992, 17222022, 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, 17222265, 17222269, 17222527, 17222530, 17222583, 17222586, 17230051, 17230075 and 17230067
Expiration Date(s): 5/31/2024, 6/30/2024, 7/31/2024, 8/31/2024, 9/30/2024, 10/31/2024 and 11/30/2024

What you should do:

  • Do not continue to use POTASSIUM CHLORIDE 10 MEQ if it has been recalled
  • Check your prescription label to see if you have any POTASSIUM CHLORIDE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

POTASSIUM CHLORIDE 10 MEQ (NDC#68462035705)

POTASSIUM CHLORIDE 10 MEQ

On 07/24/2024, Glenmark Pharmaceutical recalled POTASSIUM CHLORIDE 10 MEQ due to failed dissolution specifications. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: POTASSIUM CHLORIDE 10 MEQ
NDC Number: 68462035705
Lot Number(s): 17221197, 17221386, 17221385, 17221489, 17221504, 17221530, 17221561, 17221579, 17221568, 17221702, 17221704, 17221898, 17221993, 17222029, 17222300, 17222304, 17222278, 17222609, 17222395, 17222589, 17222605 and 17222613
Expiration Date(s): 5/31/2024, 6/30/2024, 7/31/2024, 8/31/2024, 10/31/2024 and 11/31/2024

What you should do:

  • Do not continue to use POTASSIUM CHLORIDE 10 MEQ if it has been recalled
  • Check your prescription label to see if you have any POTASSIUM CHLORIDE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

DULOXETINE HCL 60 MG

DULOXETINE HCL 60 MG

On 6/26/2024, Breckenridge Pharmaceutical, Inc recalled DULOXETINE HCL 60 MG due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), Nnitroso-duloxetine, above the proposed interim limit.. The U.S. Food and Drug Administration
(FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DULOXETINE HCL 60 MG
NDC Number: 51991074890
Lot Number(s): 230035C and 230101C
Expiration Date(s): 11/30/2025 and 12/31/2025

What you should do:

Do not continue to use DULOXETINE HCL 60 MG if it has been recalled

  • Check your prescription label to see if you have any DULOXETINE HCL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

METOPROLOL TARTRATE 25 MG

METOPROLOL TARTRATE 25 MG

On 06/05/2024, Rubicon Research Private Limited recalled METOPROLOL TARTRATE 25 MG due to the presence of a foreign substance: metal in tablet. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: METOPROLOL TARTRATE 25 MG NDC Number: 52817036000 Lot Number(s): 231037H1
Expiration Date(s): 06/2027

What you should do:

  • Do not continue to use METOPROLOL TARTRATE 25 MG if it has been recalled
  • Check your prescription label to see if you have any METOPROLOL TARTRATE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

RIZATRIPTAN 10 MG

RIZATRIPTAN 10 MG

On 06/12/2024, Glemark Pharmaceuticals recalled RIZATRIPTAN 10 MG due to impurity results that are above the FDA acceptable limits. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: RIZATRIPTAN 10 MG NDC Number: 68462046699 Lot Number(s): 19224217, 19233789 and 19224444
Expiration Date(s): 09/2024, 09/2025 and 09/2024

What you should do:

  • Do not continue to use RIZATRIPTAN 10 MG if it has been recalled
  • Check your prescription label to see if you have any RIZATRIPTAN in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LOSARTAN POTASSIUM 25 MG

LOSARTAN POTASSIUM 25 MG

On July 12 2023, STRIDES PHARMA recalled LOSARTAN POTASSIUM 25 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LOSARTAN POTASSIUM 25 MG
NDC Number: 64380093308
Lot Number:
7901903A
Expiration Date: 04/30/2024

What you should do:

  • Do not continue to use LOSARTAN POTASSIUM 25 MG if it has been recalled
  • Check your prescription label to see if you have any LOSARTAN POTASSIUM in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

INSULIN GLARGINE-YFGN 100/ML

INSULIN GLARGINE-YFGN 100/ML

On May 4, 2022, MYLAN SPECIALTY recalled INSULIN GLARGINE-YFGN 100/ML due to labeling being absent from the vial. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: INSULIN GLARGINE-YFGN 100/ML
  • NDC Number: 49502039380
  • Lot Number(s): BF21002800
  • Expiration Date(s): 8/2023

What you should do:

  • Do not continue to use INSULIN GLARGINE-YFGN 100/ML if it has been recalled
  • Check your prescription label to see if you have any INSULIN GLARGINE-YFGN in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

HUMALOG 100/ML

HUMALOG 100/ML

On May 25, 2022, CARDINAL HEALTH recalled HUMALOG 100/ML due to exposure to extreme temperatures. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: HUMALOG 100/ML
  • NDC Number: 00002751659
  • Lot Number(s): UNKNOWN
  • Expiration Date(s): UNKNOWN

What you should do:

  • Do not continue to use HUMALOG 100/ML if it has been recalled
  • Check your prescription label to see if you have any HUMALOG in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

TRAVOPROST 0.004 %

TRAVOPROST 0.004 %

On April 13, 2022, MYLAN recalled TRAVOPROST 0.004 % due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the
affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: TRAVOPROST 0.004 %
  • NDC Number: 00378965132
  • Lot Number(s): TV11W101
  • Expiration Date(s): Mar 2023

What you should do:

  • Do not continue to use TRAVOPROST 0.004 % if it has been recalled
  • Check your prescription label to see if you have any TRAVOPROST in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

GLYCOPYRROLATE 1 MG

GLYCOPYRROLATE 1 MG

On April 6, 2022, AUROBINDO PHARMA recalled GLYCOPYRROLATE 1 MG due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: GLYCOPYRROLATE 1 MG
  • NDC Number: 13107001401
  • Lot Number(s): 01421008A1
  • Expiration Date(s): 03/2023

What you should do:

  • Do not continue to use GLYCOPYRROLATE 1 MG if it has been recalled
  • Check your prescription label to see if you have any GLYCOPYRROLATE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

 

View past recalls still in effect:

GLUCAGON EMERGENCY KIT 1 MG

GLUCAGON EMERGENCY KIT 1 MG

On October 20, 2021, ELI LILLY & CO. recalled GLUCAGON EMERGENCY KIT 1 MG due to sub-potency. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.
More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: GLUCAGON EMERGENCY KIT 1 MG
  • NDC Number: 00002803101
  • Lot Number(s): D239382D
  • Expiration Date(s): April 2022

What you should do:

  •  If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

METFORMIN HCL ER 750 MG

METFORMIN HCL ER 750 MG

On June 30, 2021, VIONA PHARMACEUTICALS, INC recalled METFORMIN HCL ER 750 MG due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.
More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: METFORMIN HCL ER 750 MG
  • NDC Number: 72578003601
  • Lot Number(s): M1915601 and M915602
  • Expiration Date(s): Oct 2021

What you should do:

  •  If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

BUSPIRONE HCL 15 MG

BUSPIRONE HCL 15 MG

On June 6, 2021, OXFORD PHARMACEUTICALS, LLC recalled BUSPIRONE HCL 15 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: BUSPIRONE HCL 15 MG
  • NDC Number: 69584009310
  • Lot Number(s): C21021A
  • Expiration Date(s): 03/2023

What you should do:

  •  If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

NP THYROID ALL STRENGTHS

NP THYROID ALL STRENGTHS

On June 2, 2021, ACELLA PHARMACEUTICALS, LLC recalled NP THYROID due to sub-potency. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.
More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: NP THYROID ALL STRENGTHS
  • NDC Number: 42192032701, 42192032707, 42192032901, 42192032907, 42192033001, 42192033101, 42192032801, 42192032807

Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

HALOPERIDOL DECANOATE 50 MG/ML and 100 MG/ML

HALOPERIDOL DECANOATE 50 MG/ML and 100 MG/ML

On May 26, 2021, TEVA PHARMACEUTICALS recalled HALOPERIDOL DECANOATE due to the possibility of the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: HALOPERIDOL DECANOATE 50 MG/ML and 100 MG/ML
  • NDC Number: 00703712103, 00703713103
  • Lot Number(s): 31325793C, 31325394C, 31327161B
  • Expiration Date(s): 09/2021, 04/2022

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

CEFPROZIL 250 MG/5ML

CEFPROZIL 250 MG/5ML

On April 21, 2021, LUPIN PHARMACEUTICALS, INC recalled CEFPROZIL 250 MG/5ML due to potency concerns. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: CEFPROZIL 250 MG/5ML
  • NDC Number: 68180040201, 68180040202, 68180040203
  • Lot Number(s): F801122, F801123, F801124
  • Expiration Date(s): June 2021

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

GUANFACINE 2 MG ER TABLETS

GUANFACINE 2 MG ER TABLETS

On April 14, 2021, APOTEX recalled GUANFACINE 2 MG ER TABLETS due to possible cross-contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: GUANFACINE 2 MG ER TABLETS
  • NDC Number: 60505-3928-01
  • Lot Number(s): RX1662, RX1663, RX1664
  • Expiration Date(s): 11/2022

What you should do:

  • If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

MOMETASONE FUROATE 0.1 %

MOMETASONE FUROATE 0.1 %

On April 14, 2021, COSETTE PHARMACEUTICALS, INC recalled MOMETASONE FUROATE 0.1 % due to potency concerns. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: MOMETASONE FUROATE 0.1 %
  • NDC Number: 00713-0701-85, 00713-0701-53
  • Lot Number(s): 1014611, 1014612, 1014593, 1014594, 1014595
  • Expiration Date(s): 10/2022, 12/2022

What you should do:

If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

RIOMET 500 MG/5ML

RIOMET 500 MG/5ML

On April 21, 2021, SUN PHARMACEUTICAL INDUSTRIES, INC. recalled RIOMET 500 MG/5ML due to contamination concerns. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: RIOMET 500 MG/5ML
  • NDC Number: 10631020602
  • Lot Number(s): J190386A, X190354A, A200035A, B200064A, H200236A
  • Expiration Date(s): 3/2021, 5/2021, 6/2021, 8/2021, 1/2022

What you should do:

  • If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

FAMOTIDINE 40 MG TABLETS

FAMOTIDINE 40 MG TABLETS

On March 10, 2021, AUROBINDO PHARMA recalled FAMOTIDINE 40MG due to the possibility of a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: FAMOTIDINE 40 MG
  • NDC Number: 65862-0860-99
  • Lot Number(s): P2000467
  • Expiration Date(s): 7/2022

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

OMEPRAZOLE 20 MG

OMEPRAZOLE 20 MG

On March 24, 2021, BRECKENRIDGE recalled OMEPRAZOLE 20 MG due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: OMEPRAZOLE 20 MG
  • NDC Number: 51991064310
  • Lot Number(s): 191659
  • Expiration Date(s): 05/20/21

What you should do:

  • If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178

CEPHALEXIN 250mg/5mL Suspension

CEPHALEXIN 250mg/5mL Suspension

On February 24, 2021, Ascend Laboratories recalled CEPHALEXIN 250mg/5mL suspension due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CEPHALEXIN 250 MG/5ML
NDC Number: 67877-0545-88, 67877-0545-68
Lot Number(s): 19144841, 20141673, 19141869, 19141870, 19142762, 19143826, 19143923,19143941, 19143954
Expiration Date(s): 9/2021, 2/2022, 5/2021, 7/2021

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Enoxaparin Sodium Injection 100mg/mL and 120mg/0.8mL

Enoxaparin Sodium Injection 100mg/mL and Enoxaparin Sodium Injection 120mg/0.8mL

On February 18, 2021, Apotex Corporation recalled Enoxaparin Sodium due to a possible labeling mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: Enoxaparin Sodium Injection 100mg/mL and Enoxaparin Sodium Injection 120mg/0.8mL
  • NDC Number: 60505079604, 60505079600, 60505079504, 60505079501
  • Lot Number(s): CS008, CT003
  • Expiration Date(s): 04/2022, 05/2022

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 750mg

Metformin ER 750mg

On February 10, 2021, Nostrum Laboratories, Inc. recalled Metformin ER 750mg due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

  • The detailed information of the recalled product is listed below:
    Recalled Drug: METFORMIN HCL ER 750 MG
  • NDC Number: 29033005601
  • Lot Number(s): MET200601
  • Expiration Date(s): 07/2022

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Nortriptyline 10mg Capsule

Nortriptyline 10mg Capsule

On February 10, 2021, Taro Pharmaceuticals U.S.A., Inc. recalled Nortriptyline 10mg capsules due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

  • Recalled Drug: NORTRIPTYLINE HCL 10 MG
  • NDC Number: 51672-4001-01
  • Lot Number(s): AC05096, AC05098, and AC05099
  • Expiration Date(s): 10/31/2022

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.

• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

PAROEX 0.12 %

PAROEX 0.12 %

On December 2, 2020, SUNSTAR AMERICA recalled PAROEX 0.12 % due to a possible tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class I of the affected medications.
More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:
Recalled Drug: PAROEX 0.12 %
NDC Number: 52376002102
Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:
• Do not continue to use PAROEX 0.12 % if it has been recalled
• Check your prescription label to see if you have any PAROEX in the affected lot numbers and expiration dates.
• If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

MESALAMINE 1.2 G

MESALAMINE 1.2 G

On 11/18/2020, ACTAVIS/TEVA recalled MESALAMINE due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.
More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: MESALAMINE 1.2 G
NDC Number: 00591-2245-22
Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:
• Do not continue to use MESALAMINE 1.2 G if it has been recalled.
• Check your prescription label to see if you have MESALAMINE of the affected lot numbers and
expiration dates.
• If you have the medication, contact the pharmacy that you received it from.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

NP THYROID 15mg and 120mg

NP THYROID 15mg and 120mg

On October 28, 2020, ACELLA PHARMACEUTICALS, LLC recalled NP THYROID 15mg and 120mg due to a sub-potency concerns. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               NP THYROID 15mg and 120mg
NDC Number:               
42192-0327-01, 42192-0328-01
Lot Number(s):             
M327E19-1, M328F19-3
Expiration Date(s):     
10/2020, 11/2020

What you should do:

  • Do not continue to use NP Thyroid if it has been recalled
  • Check your prescription label to see if you have any LISINOPRIL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

BUPRENORPHINE 5 MCG/HR

 

BUPRENORPHINE 5 MCG/HR

On October 7, 2020, TEVA USA recalled BUPRENORPHINE due to sub-potency concerns. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               BUPRENORPHINE 5 MCG/HR
NDC Number:               
00093365640
Lot Number(s):             
190017, 190161
Expiration Date(s):        
02/2021, 08/2021

What you should do:

  • Do not continue to use BUPRENORPHINE 5 MCG/HR if it has been recalled.
  • Check your prescription label to see if you have BUPRENORPHINE of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

MIBELAS 24 FE 1MG-20(24)

 

MIBELAS 24 FE 1MG-20(24)

On August 19, 2020, LUPIN PHARMACEUTICALS recalled MIBELAS 24 FE due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a CLASS II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:   MIBELAS 24 FE 1MG-20(24)
NDC Number:  
68180091113
Lot Numbers:   
L900017, L900070, L900589, L901085, L901008, L901641, L901735
Expiration Date: 
12/31/2020, 3/31/2021, 4/30/2021, 6/30/2021, 10/31/2021

What you should do:

  • Do not continue to use MIBELAS 24 FE 1MG-20(24) if it has been recalled.
  • Check your prescription label to see if you any MIBELAS 24 FE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 500mg and 1000mg tablets

 

Metformin ER 500mg and 1000mg tablets
(Manufactured by Lupin Pharmaceuticals)

On July 22, 2020, Lupin Pharmaceuticals recalled Metformin ER 750mg and 1000mg due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Metformin ER 500mg and 1000mg
NDC Number:
68180033801, 68180033607, 68180033909, 68180033707
Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication.

What you should do:

  • Do not continue to use Metformin ER 750mg or 1000mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 750mg

Metformin ER 750mg
(manufactured by Granules Pharmaceuticals)

On 7/22/2020, Granules Pharmaceuticals recalled Metformin ER due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:   Metformin ER
NDC Number:     
70010-0492-01, 70010-0492-05
Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication.

What you should do:

  • Do not continue to use Metformin ER 750mg if it has been recalled.
  • Check your prescription label to see if you any Metformin ER in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

AURYXIA 210MG IRON TABLETS

 

AURYXIA 210MG IRON TABLETS

On July 22, 2020 KERYX BIOPHARMACEUTICALS recalled AURYXIA due to lack of quality assurance as determined by the FDA. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:   AURYXIA 210MG IRON
NDC Number:     
59922063101
Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication.

What you should do:

  • Do not continue to use AURYXIA 210MG IRON if it has been recalled.
  • Check your prescription label to see if you have any AURYXIA in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LISINOPRIL 10 MG

 

LISINOPRIL 10 MG

On August 5, 2020, BLUEPOINT LABORATORIES recalled LISINOPRIL 10 MG due to a possible tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:LISINOPRIL 10 MG
NDC Number:68001033408
Lot Numbers:  Q000232
Expiration Date:  01/2022

What you should do:

  • Do not continue to use LISINOPRIL 10 MG if it has been recalled
  • Check your prescription label to see if you have any LISINOPRIL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 500mg and 750mg

 

Metformin ER 500mg and 750mg

multiple manufactuers are recalling Metformin 500mg and 700mg Extended Release Tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Metformin ER 500mg and 750mg
NDC Number:
Due to the high volume of NDC numbers affected, please refer to the FDA website link above for specific information regarding the NDC(s), lot number(s) and expiration date(s) related to your medication.

What you should do:

  • Do not continue to use any medication that has been recalled.
  • Check your prescription label to see if you have Metformin ER 500mg or 750mg in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

NP Thyroid 30mg, 60mg, 90mg

NP Thyroid 30mg, 60mg, 90mg

On June 10, 2020, Acella Pharmaceuticals, LLC, recalled NP Thyroid due to sub-potency. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               NP Thyroid 30mg, 60mg, 90mg
NDC Numbers:             
42192032901, 42192033001, 42192033101
Lot Numbers:               
M329H18-1, M329J18-1, M329J18-2, M329J18-3, M329M18-2, M329A19-1, M330J18-2A, M330J18-3, M331G18-1, M331J18-1, M331J18-2, M331M18-1, M331M18-2
Expiration Dates:          JUN-2020, JUL-2020, AUG-2020, NOV-2020, DEC-2020

What you should do:

  • Do not continue to use NP Thyroid if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Mirtazapine 15mg tablets

 

Mirtazapine 15mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled MIRTAZAPINE 15mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               Mirtazapine 15mg
NDC Number:               
13107-0031-34, 65862-0198-99
Lot Numbers:
                031180028A
Expiration Date:           
03/2021

What you should do:

  • Do not continue to use MIRTAZAPINE 15mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Oxycodone/acetaminophen 10/325mg tablets

Oxycodone/acetaminophen 10/325mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled OXYCODONE/ACETAMINOPHEN 10/325mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               Oxycodone/acetaminophen 10/325mg
NDC Number:               
13107-0046-01
Lot Numbers:
                046180056A
Expiration Date:           
05/2020

What you should do:

  • Do not continue to use OXYCODONE/ACETAMINOPHEN if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Mirtazapine 15mg tablets

 

Mirtazapine 15mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled MIRTAZAPINE 15mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               Mirtazapine 15mg
NDC Number:               
13107-0031-34, 65862-0198-99
Lot Numbers:
                031180028A
Expiration Date:           
03/2021

What you should do:

  • Do not continue to use MIRTAZAPINE 15mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LISINOPRIL 30 MG

 

LISINOPRIL 30 MG

On April 8, 2020, LUPIN PHARMACEUTICALS, INC. recalled LISINOPRIL due to the possibility of a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               LISINOPRIL 30 MG
NDC Number:               
68180098201
Lot Numbers:               
Q900580
Expiration Date:           
9/2021

What you should do:

  • Do not continue to use LISINOPRIL 30 MG if it has been recalled.
  • Check your prescription label to see if you any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Levetiracetam 750mg tablets

 

Levetiracetam 750mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled LEVETIRACETAM 750mg due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:     Levetiracetam 750mg
NDC Number:   
65862-0053-90
Lot Numbers:
      24719001A1
Expiration Date:  
03/2021

What you should do:

  • Do not continue to use LEVETIRACETAM 750mg if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

GLYCOPYRROLATE 1 MG

 

GLYCOPYRROLATE 1 MG

On April 8, 2020, PAR PHARM. recalled GLYCOPYRROLATE 1 MG due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:  GLYCOPYRROLATE 1 MG
NDC Number:   
49884006501
Lot Numbers:
    32809101
Expiration Date: 
3/2021

What you should do:

  • Do not continue to use GLYCOPYRROLATE 1 MG if it has been recalled
  • Check your prescription label to see if you any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Gabapentin 100mg Capsule

 

Gabapentin 100mg Capsule

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled GABAPENTIN 100mg due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               Gabapentin 100mg
NDC Number:               
65862-0198-99
Lot Numbers:
                198180048A, 198180061A, 19819017A1
Expiration Date:           
04/2021, 06/2020, 02/2021

What you should do:

  • Do not continue to use GABAPENTIN 100mg if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Daytrana (methylphenidate) 10mg, 20mg, and 30mg patches

 

Daytrana (methylphenidate) 10mg, 20mg, and 30mg patches

On April 29, 2020, Noven Therapeutics, LLC, recalled Daytrana 10mg, 20mg, and 30mg patches due to the possibility of the patch being defective. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:  Daytrana 10mg, 20mg, and 30mg
NDC Number:
68968-5552-03, 68968-5554-03, 68968-5555-03
Lot Numbers:
  886647, 86354, 86355, 86356, 86550, 87348, 87965
Expiration Date:
09/2020, 08/2020, 07/2020, 08/2020, 07/2020, 01/2021. 01/2021

What you should do:

  • Do not continue to use DAYTRANA 10mg, 20mg, and 30mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Acetaminophen with Codeine 300/15mg, 300/30mg, 300/60mg

 

Acetaminophen with Codeine 300/15mg, 300/30mg, 300/60mg

On April 8, 2020, Aurobindo Pharma, USA, Inc., recalled acetaminophen with codeine due to possible contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:               Acetaminophen with Codeine 300/15mg, 300/30mg, 300/60mg
NDC Number:                13107005801, 13107005999, 13107006001, 52959000310, 52959000312,                                                              52959000314, 52959000316, 52959000320, 52959000330, 52959000360
Lot Numbers:               
058180015A, 058180016A, 05818017B1, 059180023A, 059180024A, 059180025A,                                                     060180017A, 060180019B1, 060180020A and 060180021A
Expiration Date:           
07/2021, 09/2021, 05/2021, 06/2021

What you should do:

  • Do not continue to use any of the affected drug if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Daytrana (methylphenidate) 10mg, 15mg, 20mg, and 30mg patches

 

Daytrana (methylphenidate) 10mg, 15mg, 20mg, and 30mg patches

On March 25, 2020, Noven Therapeutics Associates, Inc., recalled Daytrana due to the possibility of the patch being defective. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:            Daytrana Patches (all strengths)
NDC Number(s):       
68968555203, 68968555303, 68968555403, 68968555503
Lot Number(s):          
86280, 85942, 86281, 86081, 86196, 86083, 86282
Expiration Date:        
06/2020, 03/2020, 06/2020, 04/2020, 05/2020, 06/2020

What you should do:

  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Sotalol AF 80mg

 

Sotalol AF 80mg

On March 25, 2020, Mylan Pharmaceuticals recalled Sotalol due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:         Sotalol AF 80mg
NDC Number:            00378512301
Lot Number:              3095754
Expiration Date:     02/2021

What you should do:

  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Phenytoin 125mg/5mL oral suspension

 

Phenytoin 125mg/5mL oral suspension

On February 21, 2020, Taro Pharmaceuticals, USA, Inc., recalled Phenytoin 125mg/5mL due to potency concerns. This is a voluntary recall from the manufacturer, therefore, it is being treated as a Class I Recall.

More information about the recall is at: FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                Phenytoin 15mg/5mL
NDC Number:                
51672-4069-01
Lot Numbers:
                   327874, 327876
Expiration Date:             
December 2020

What you should do:

  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have some of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Ranitidine 150mg and 300mg Tablets

 

Ranitidine 150mg and 300mg Tablets

On January 15, 2020, Glenmark Pharmaceuticals recalled Ranitidine Tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                Ranitidine 150mg and 300mg Tablets
NDC Number(s):           
68462024860, 68462024801, 68462024930, 68462024901, 68462024920,                                                              68462024805, 70518171400, 65162025310
Due to the high number of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:

  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Lamotrigine 100mg Tablet

 

Lamotrigine 100mg Tablet

On January 10, 2020, Taro Pharmaceuticals U.S.A., Inc., recalled LAMOTRIGINE 100MG due to a possible cross-contamination. The U.S. Food and Drug Administration (FDA) has not yet issued recall of the affected medications, however, the company has voluntarily recalled the below affected lot number at the consumer level.

More information about the recall is at: https://www.fda.gov/drugs/drugsafety/drugRecalls/default.htm

The detailed information of the recalled product is listed below:

Recalled Drug:                Lamotrigine 100mg
NDC Number:                
51672-4131-01
Lot Number(s):              
331771
Expiration Date:            
June, 2021

What you should do:

  • Do not continue to use Lamotrigine 100mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Blisovi FE 1.5/30mg, 21 Tablets per pack

 

Blisovi FE 1.5/30mg, 21 Tablets per pack

On January 15, 2020, Lupin Pharmaceuticals recalled Blisovi FE due to complaints related to crumbling of tablets when popped out of the blister pack. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:                BLISOVI FE 1.5-30(21)
NDC Number:                
68180086611
Lot Number(s):              
H801227
Expiration Date:            
January, 2020

What you should do:

  • Do not continue to use this drug if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Nystatin Oral Suspension 10,000 units per mL

Nystatin Oral Suspension 10,000 units per mL

On February 5, 2020, Pharmaceutical Associates, Inc., recalled Nystatin Oral Suspension 10,000 units per mL due to possible sub-potency issues. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug:                NYSTATIN 100000/ML
NDC Number:                
00121081016
Lot Numbers:                   BB70, BB71
Expiration Date:            
May 2020

What you should do:

  • Do not continue to use this medication if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Ranitidine

On December 9, 2019, Amneal Pharmaceuticals, Inc., recalled Ranitidine 150mg and 350mg tablets, as well as Ranitidine 15mg/mL oral solution, due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Ranitidine 150mg, 300mg tablets, 15mg/mL oral solution
NDC Number:                 
65162-253-06, 65162-253-10, 65162-253-18, 65162-253-50, 65162-253-11, 65162-254-30, 65162-254-10, 65162-254-25, 65162-664-90
Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

What you should do:

  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Levetiracetam Oral Solution 100mg/mL

On December 27, 2019, Lanett Company, Inc. recalled Levetiracetam 100mg/mL due to contamination. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is available on the FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                 LEVETIRACETAM 100mg/mL
NDC Number:                 
54838054880
Lot Numbers:
                    2190A, 2191A
Expiration Date:             
07/2021

Relpax 40mg Tablet

On 10/14/2019, Pfizer Inc. recalled Relpax 40mg tablets due to potential microbial contamination of non-sterile products. The U.S. Food and Drug Administration (FDA) has issued a recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Relpax 40mg Tablet
NDC Number:                 
0049-2340-45, 0049-2340-05
Lot Numbers:                   
AR5407, CD4565
Expiration Date:           
   02/22

Ranitidine Hydrochloride (HCL)

On 09/23/2019, SANDOZ recalled RANITIDINE HCL due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Ranitidine 150mg and Ranitidine 300mg
NDC Number:                 
00781285560, 00781286531
Lot Numbers:                 
HD8625, HD9275, HU2207, HX6676, HX6677, HC9266, HD1865, HP9441, JK7994, JK8659, HD1862, HP9438, HP9439, HP9440
Expiration Date:            
4/30/2020, 4/30/2020, 8/31/2020, 3/31/2021, 3/31/2021, 4/30/2020, 4/30/2020, 9/30/2020, 8/31/2021, 8/31/2021, 4/30/2020, 9/30/2020, 9/30/2020, 9/30/2020

Losartan Potassium/Hydrochlorothiazide

On 9/19/2019, Torrent Pharma, Inc., recalled Losartan Potassium (all strengths) and Losartan Potassium/Hydrochlorothiazide (all strengths) due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Losartan Potassium and Losartan Potassium/Hydrochlorothiazide
NDC Number:                 
13668-409-10, 13668-115-90, 13668-115-10, 13668-116-90, 13668-118-90
Lot Numbers:                 
4DU2E009, 4DU3E009, 4DU3D018, BEF7D051, 4P04D007
Expiration Date:            
12/31/2020, 02/28/2021

Clobazam Oral Suspension 2.5mg/mL

On 7/16/2019, Bionpharma, Inc. recalled Clobazam Oral Suspension 2.5mg/mL due to out-of-specification results for Microbial Enumeration Tests. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall can be found on the FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                 Clobazam Oral Suspension 2.5mg/mL
NDC Number:                 
69452-116-45
Lot Numbers:                 
18246
Expiration Date:            
09/2020

Hydrocodone/Chlorpheniramine 10/8mg/5ml

On 07/11/2019, Tris Pharma, Inc. recalled Hydrocodone/Chlorpheniramine 10/8mg/5mL due to incorrect potency. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications.

More information about the recall can be found on the FDA website.

The detailed information of the recalled product is listed below:

Recalled Drug:                 Hydrocodone/Chlorpheniramine 10/8mg/5mL
NDC Number:                  27808-086-02
Lot Numbers:                 
14079
Expiration Date:            
10/2021 

Losartan

On 5/3/2019, Heritage Pharmaceuticals Inc. and Torrent Pharma Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 2/28/2019, Camber Pharmaceuticals Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On 4/10/2019, Torrent Pharma, Inc. recalled Losartan potassium tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171978

The detailed information of the recalled product is listed below:

Recalled drug: Losartan 25mg, 50mg, 100 mg tablets | Losartan Potassium Tablets (all strengths) 

NDC numbers: 31722070010, 31722070130, 31722070290
Lot numbers:
Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.

Acyclovir 400mg tablets

On 4/25/2019, Zydus Pharmaceuticals recalled Acyclovir 400mg tablets due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172494

The detailed information of the recalled product is listed below:

Recalled drug:  Acyclovir 400mg tablets, 100 count bottles
NDC number: 
68382079101
Lot numbers:
Z804517
Expiration date:
11/30/2020

Fentanyl Transdermal Patch, 12mcg/hr

On 4/19/2019, Alvogen, Inc recalled Fentanyl 12mcg/hr transdermal patches due to a packaging mix-up leading to the incorrect strength in respective boxes. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172322

The detailed information of the recalled product is listed below:

Recalled drug: Fentanyl 12mcg/hr transdermal patch
NDC number:
47781042347
Lot numbers and expiration date:
Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.

Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg

On 3/1/2019, Apotex Inc. recalled Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is available on the FDA website

The detailed information of the recalled product is listed below:

Recalled Drug:                 Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg
NDC Number:                 
60505418303
Lot Numbers:
                 7DY008A, 7DY009A, 7DY010A, 7DY011A
Expiration Date:            
08/2020 

Irbesartan 300 mg Tablets

On 1/18/2019, Prinston Pharmaceutical Inc. recalled Irbesartan 300mg Tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170280

The detailed information of the recalled product is listed below:

Recalled Drug: Irbesartan 300mg Tablets
NDC Number:
43547-376-09
Lot Numbers:
331B18009

Quetiapine Fumarate 400mg

On November 14, 2018, ASCEND LABORATORIES recalled QUETIAPINE FUMARATE 400 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. This is an ongoing FDA drug recall.

Recalled Drug: Quetiapine Fumarate 400mg

NDC Number: 67877024801

Lot Number: 7143908

Expiration Date: November 2020

Valsartan, Valsartan-Hydroclorothiazide & Amlodipine-Valsartan

On 1/18/2019, Aurobindo Pharma USA Inc. recalled Valsartan 160mg, 320mg, 40mg, 80mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

On November 20, 2018 Mylan recalled Amlodipine-Valsartan &  Valsartan due to the detection of trace amounts of the impurity NDEA (N-Nitrosodiethylamine) found in the active pharmaceutical ingredient of Valsartan. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications.

More information about the recall is available on the FDA website

Recalled Drug: 

  • Valsartan 40 mg, 60 mg, 80 mg, 160 mg, and 320 mg
  • Amlodipine-Valsartan 5/160 mg, 10/160 mg and 10/320 mg
  • Valsartan-Hydrochlorathiazide 320/25 MG 

NDC Number: 65862057290, 65862057390, 65862057030, 65862057190, 00378-1721-93, 00378-1722-93, 00378-1724-93, 00378-5813-77, 00378-5814-77, 00378-5807-93, 0378-5815-77 and 0378-6325-05

Lot Number: 3079500, 3061986, 3079709, 3077618, 3079708, 3063782, 3071352, 3061169, 3081499, 3080009, 3080010, 3079205, 3084886, 3093804

Expiration Date:  November 2018, January 2019, March 2019, July 2019, November 2019, December 2019, January 2020, February 2020, March 2020

Tizanidine HCL 2 mg

On 09/04/2018, Dr. Reddy’s Lab recalled Tizanidine HCL 2 MG due to a tablet mix-up. Glimepiride tablets were found in bottles of Tizanidine.  The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medication.  

Recalled Drug: Tizanidine HCL 2 mg

NDC Number: 55111017915

Lot Numbers: T800304

Expiration Date: 03/2021

Diphenoxylate & Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: 2021 OCT 31, 2021 NOV 30

Fluticasone 50mcg

On 05/31/2018, Apotex Corp recalled Fluticasone 50mcg due to the potential presence of embedded and loose particles within the medication. The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall of the affected medications.

Recalled Drug: Fluticasone 50mcg

NDC Number: 60505-0829-01

Lot Number: NJ4501

Expiration Date: 07/2020

Diphenoxylate and Atropine 2.5 mg/0.025mg

On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg

NDC Number: 59762-1061-01 and 59762-1061-02

Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834

Expiration Date: Oct 31, 2021, Nov 30, 2021

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