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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Amneal Pharmaceuticals of New York, LLC: Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: June 25, 2020
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Summary

Amneal Pharmaceuticals has voluntarily recalled several lots of Metformin Hydrochloride Extended-Release Tablets (500 mg and 750 mg) due to the detection of N-Nitrosodimethylamine (NDMA). NDMA is a substance that is classified as a probable human carcinogen. This recall affects approximately 192 units distributed nationwide across various bottle sizes including 90-count, 100-count, 500-count, and 1000-count bottles, as well as bulk containers.

Risk

Testing revealed that certain lots contained NDMA levels above the acceptable daily intake limit. Long-term exposure to levels of NDMA above these limits may increase the risk of developing cancer.

What You Should Do

  1. Check your medication bottle for the product name 'Metformin Hydrochloride Extended-Release Tablets' in either 500 mg or 750 mg strengths.
  2. Verify the NDC number and Lot numbers on your prescription bottle. Affected NDC numbers include 53746-0178-01, 65162-178-09, 65162-178-50, 65162-178-10, 53746-0179-01, 65162-179-10, 53746-0178-05, 53746-0178-10, 65162-0178-11, and 53746-0178-90.
  3. Consult the extensive list of affected lot numbers and expiration dates, such as HA07419A (Exp 1/31/2021), AM190123A (Exp 1/31/2021), and HM00118A (Exp 11-2020), to confirm if your specific bottle is part of the recall.
  4. Continue taking your medication until you speak with your doctor. It can be dangerous for patients with type 2 diabetes to stop taking their metformin without first discussing an alternative treatment with a healthcare professional.
  5. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. Return any unused product to your pharmacy for a refund.
  6. Contact Amneal Pharmaceuticals LLC for further instructions or questions regarding this recall at their website: www.fda.gov/safety/recalls.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (100 count bottles)
Model:
NDC 53746-0178-01
Lot Numbers (193):
HA07419A
HB00119A
HB00219A
HB00319A
HB00419A
HB00519A
HB00619A
HB00719A
HB00819A
HB00919A
HB01019A
HB05119A
HB05219A
HB05319A
HB05419A
HB05519A
HB09519A
HB09619A
HB09719A
HB09819A
HB09919A
HC08219A
HC08319A
HC08419A
HC08519A
HC09019A
HC09119A
HC09219A
HC09319A
HC09419A
HD03419B
HD03519B
HD03619B
HD03719B
HD03819B
HD03919B
HD04019B
HD04119B
HD04219A
HD05819A
HD05919A
HD06019A
HD06119A
HD06219A
HD06319A
HD06419A
HD09019A
HD09119A
HD09219A
HE01219B
Date Ranges: Exp 1/31/2021, Exp 2/28/2021, Exp 3/31/2021, Exp 4/30/2021, Exp 5/31/2021, Exp 6/30/2021, Exp 6/30/2020, Exp 7/31/2021, Exp 8/31/2020, Exp 9/30/2020, Exp 10/31/2020, Exp 12/31/2020
Product: amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg (90 Tablets bottles)
Model:
NDC 65162-178-09
Lot Numbers (65):
AM190123A
AM190193A
AM190194A
AM190195A
AM190196A
AM190197A
AM190198A
AM190199A
AM190200A
AM190201A
AM190202A
AM190269A
AM190270A
AM190271A
AM190272A
AM190289A
AM190290A
AM190291A
AM190292A
AM190293A
AM190294A
AM190549A
AM190550A
AM190551A
AM190552A
AM190553A
AM190554A
AM190555A
AM190556A
AM190586A
AM190587A
AM190588A
AM190589A
AM190590A
AM190605A
AM190673A
AM190707A
AM190708A
AM190709A
AM190710A
AM190714C
AM190751C
AM190752C
AM190753A
AM190754A
AM190755A
AM190756A
AM190757A
AM190929A
AM190930A
Date Ranges: Exp 1/31/2021, Exp 2/28/2021, Exp 4/30/2021, Exp 5/31/2021, Exp 6/30/2021, Exp 8/31/2021, Exp 9/30/2021
Product: amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg (500 Tablets bottles)
Model:
NDC 65162-178-50
Lot Numbers (97):
AM180641A
AM180642A
AM180643A
AM180644A
AM180645A
AM180646A
AM180647A
AM180880A
AM180881A
AM180882A
AM180883A
AM180884A
AM180885A
AM180886A
AM180887A
AM180888A
AM180889A
AM180936A
AM180937A
AM180938A
AM180939A
AM180940A
AM180960A
AM180961A
AM180962A
AM180963A
AM180964A
AM180965A
AM180992A
AM180993A
AM180994A
AM180995A
AM180996A
AM180997A
AM181037A
AM181038A
AM181039A
AM181040A
AM181041A
AM181079A
AM181080A
AM181081A
AM181082A
AM181083A
AM181084A
AM181085A
AM181086A
AM181087A
AM181088A
AM181089A
Date Ranges: Exp 6/30/2020, Exp 7/31/2020, Exp 8/31/2020, Exp 9/30/2020, Exp 10/31/2020, Exp 11/30/2020, Exp 12/31/2020, Exp 6/30/2021, Exp 10/31/2021, Exp 1/31/2022, Exp 2/28/2022
Product: amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg (100 Tablets bottles)
Model:
NDC 65162-178-10
Lot Numbers (180):
AM181118AA
AM181191AA
AM181192AA
AM181235AA
AM181236AA
AM181237AA
AM181240AA
AM181241AA
AM181242AA
AM181243AA
AM181244AA
AM181268AA
AM181269AA
AM181270AA
AM181271AA
AM181272AA
AM181273AA
AM181274AA
AM181275AA
AM181276AA
AM181277AA
AM181307AA
AM181308AA
AM181309AA
AM181310AA
AM181311AA
AM181313AA
AM181314AA
AM181315AA
AM181316AA
AM181317AA
AM181419AA
AM181420AA
AM181421AA
AM181422AA
AM181423AA
AM181424AA
AM181425AA
AM181430BA
AM181455AA
AM181456AA
AM181457AA
AM181458AA
AM181459AA
AM181460AA
AM181461AA
AM181462AA
AM181463AA
AM181464AA
AM181465AA
Date Ranges: Exp 10/31/2020, Exp 9/30/2020, Exp 11/30/2020, Exp 12/31/2020, Exp 5/31/2021, Exp 6/30/2021, Exp 8/31/2021, Exp 9/30/2021, Exp 10/31/2021, Exp 11/30/2021, Exp 12/31/2021, Exp 1/31/2022, Exp 2/28/2022
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg (100 Tablets bottles)
Model:
NDC 53746-0179-01
Lot Numbers:
HF02318A
HF02418A
HF02518A
HF07718A
HH02118A
HM04418A
HM04518A
HM04618A
HM04718A
HM05518A
HM05618A
HM05718A
HM05818A
HM05918A
HM06018A
Date Ranges: Exp 6/30/2020, Exp 7/31/2020, Exp 12/31/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg (100 Tablets bottles, India Manufacture)
Model:
NDC 65162-179-10
Lot Numbers (56):
AM181337A
AM181338A
AM181339A
AM181340A
AM181341A
AM181342A
AM181343A
AM181344A
AM181356A
AM181357A
AM181358A
AM181359A
AM181360A
AM181361A
AM181362A
AM181363A
AM181415A
AM190040B
AM190041A
AM190042A
AM190043A
AM190044A
AM190045A
AM190046A
AM190473B
AM190474A
AM190475A
AM190476A
AM190477A
AM190478A
AM190479A
AM190480A
AM190481A
AM190482A
AM190834A
AM190835A
AM190836A
AM190837A
AM190838A
AM191004A
AM191005A
AM191006A
AM191007A
AM191008A
AM191271A
AM191272A
AM191273A
AM191274A
AM191338A
AM191339A
Date Ranges: Exp 10/31/2020, Exp 11/30/2020, Exp 12/31/2020, Exp 4/30/2021, Exp 7/31/2021, Exp 8/31/2021, Exp 9/30/2021, Exp 10/31/2021, Exp 11/30/2021, Exp 12/31/2021
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk
Model:
NDC 53746-0178-BULK
Lot Numbers (121):
HA01320A
HA01420A
HA06820A
HB03620A
HB03720A
HB03820A
HB03920A
HB04020A
HB04120A
HB04220A
HB04320A
HB04420A
HB04520A
HB05020A
HB05120A
HB05220A
HB05320A
HB05420A
HB05520A
HB05620A
HB07020A
HB07120A
HB07220A
HB07320A
HB07520A
HB07620A
HB07720A
HB07820A
HB07920A
HB08020A
HB08220A
HF05519A
HF05619A
HF05719A
HF05819A
HF05919A
HF06019A
HF06119A
HF06219A
HF06319A
HF07719A
HF07819A
HF07919A
HF08019A
HF08119A
HF08219A
HF08319A
HF08419A
HF08519A
HF08619A
Date Ranges: Exp 1/31/2021, Exp 2/28/2021, Exp 6/30/2020, Exp 7/31/2020, Exp 8/31/2020, Exp 10/31/2020, Exp 11/30/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP (500 tablets bottles)
Model:
NDC 53746-0178-05
Lot Numbers:
HF06618A
HF06718A
Date Ranges: Exp 6/30/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (1000 tablets bottles)
Model:
NDC 53746-0178-10
Lot Numbers:
HF08618A
HF08718A
HF15418A
HF15518A
HH11818A
HJ00818A
HJ00918A
HJ01018A
Date Ranges: Exp 6/30/2020, Exp 7/31/2020, Exp 9/30/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (1000 tablets bottles, India Manufacture)
Model:
NDC 65162-0178-11
Lot Numbers:
HF08618A
HF08718A
HF15418A
HF15518A
HH11818A
HJ00818A
HJ00918A
HJ01018A
Date Ranges: Exp 6/30/2020, Exp 7/31/2020, Exp 9/30/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only
Model:
NDC 53746-0179-BULK
Lot Numbers:
HA01520A
HA01620A
HG01719A
HG01819A
HH09319A
HH09419A
HK07619A
HK07719A
Date Ranges: Exp 1/31/2021, Exp 7/31/2020, Exp 8/31/2020, Exp 9/30/2020, Exp 10/31/2020
Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (90 count bottle)
Model:
NDC 53746-0178-90
Lot Numbers:
HB10019A
HB10119A
HB10219A
HB10319A
HD02119A
HD03319A
HF09118A
HF11618A
HF15218A
HF15318A
HJ01418A
HJ01518A
HJ01618A
HJ01718A
HJ04718A
HK03218A
HK03318A
HK03418A
HK03518A
HK03618A
HK13718A
HK13818A
HK13918A
HK14018A
HK14118A
HK14218A
HK14318A
HK14418A
HK14518A
HM00118A
Date Ranges: 03-2021, 04-2021, 06-2020, 07-2020, 09-2020, 10-2020, 11-2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85781
Status: Active
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Sold By: authorized distributors; pharmacies
Manufactured In: United States, India
Units Affected: 192
Distributed To: Nationwide
Agency Last Updated: July 22, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.