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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

Teva Pharmaceuticals USA: Metformin ER Tablets Recalled for NDMA Impurity Above Acceptable Levels

Agency Publication Date: June 20, 2020
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Summary

Teva Pharmaceuticals USA is recalling 108,122 bottles of Metformin Hydrochloride Extended-Release (ER) Tablets, a medication used to treat type 2 diabetes. The recall includes both 500 mg and 750 mg strengths distributed under the Actavis Pharma brand. Testing by the FDA found levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit, which is a substance that could potentially increase the risk of cancer. These prescription medications were distributed nationwide across the United States and Puerto Rico.

Risk

Laboratory analysis detected N-Nitrosodimethylamine (NDMA) at levels higher than what the FDA considers safe for daily consumption. NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above the acceptable limit 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, USP' and the strength (500 mg or 750 mg).
  2. Verify if your 500 mg bottle (NDC 62037-571-01 or 62037-571-10) matches any of these lot numbers and expiration dates: 1329548A (06/2020), 1338302M (10/2020), 1348968M (10/2020), 1348969M (10/2020), 1348970M (11/2020), 1376339M (09/2021), 1323460M (06/2020), 1330919M (06/2020), 1338300A (10/2020), 1341135M (12/2020), or 1391828M (11/2021).
  3. Verify if your 750 mg bottle (NDC 62037-577-01 or 62037-577-10) matches any of these lot numbers and expiration dates: 1333338M (08/2020), 1333339A (08/2020), or 1354471A (02/2021).
  4. Do NOT stop taking your medication without first talking to your doctor or pharmacist, as the risk of stopping your diabetes treatment suddenly may be greater than the risk of exposure to the impurity.
  5. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or an alternative treatment.
  6. Contact Teva Pharmaceuticals or return any unused tablets from the affected lots to your pharmacy for a refund.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (100-count bottle)
Model:
NDC 62037-571-01
Recall #: D-1331-2020
Lot Numbers:
1329548A (Exp. 06/2020)
1338302M (Exp. 10/2020)
1348968M (Exp. 10/2020)
1348969M (Exp. 10/2020)
1348970M (Exp. 11/2020)
1376339M (Exp. 09/2021)
Date Ranges: Exp. dates 06/2020 - 09/2021
Product: Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg (1,000-count bottle)
Model:
NDC 62037-571-10
Recall #: D-1331-2020
Lot Numbers:
1323460M (Exp. 06/2020)
1330919M (Exp. 6/2020)
1338300A (Exp. 10/2020)
1341135M (Exp. 12/2020)
1391828M (Exp. 11/2021)
Date Ranges: Exp. dates 06/2020 - 11/2021
Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (100-count bottle)
Model:
NDC 62037-577-01
Recall #: D-1332-2020
Lot Numbers:
1333338M (Exp. 08/2020)
1333339A (Exp. 08/2020)
Date Ranges: Exp. date 08/2020
Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (1,000-count bottle)
Model:
NDC 62037-577-10
Recall #: D-1332-2020
Lot Numbers:
1354471A (Exp. 02/2021)
Date Ranges: Exp. date 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85797
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Actavis Pharma, Inc.; Pharmacies nationwide
Manufactured In: United States, India
Units Affected: 2 products (a) 92,793 bottles and b) 4,824 bottles; a) 15,329 bottles and b) 137 bottles)
Distributed To: Nationwide

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.