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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

Actavis Metformin Extended-Release Tablets Recalled for Excessive NDMA Levels

Agency Publication Date: March 7, 2023
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Summary

Teva Pharmaceuticals USA Inc. has recalled 12,044 bottles of Metformin hydrochloride Extended-Release Tablets, 1000 mg. The recall was issued because the medication was found to contain levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable daily intake limits. NDMA is an impurity that is classified as a probable human carcinogen. Consumers should talk to their doctor or pharmacist before they stop taking the medication, as it is important to maintain control of blood sugar levels. No injuries or illnesses have been reported to date.

Risk

The medication contains excessive levels of NDMA, an impurity that may increase the risk of cancer with long-term exposure. While NDMA is a common substance found in water and foods, the levels detected in these tablets exceed the safety thresholds established by the FDA.

What You Should Do

  1. The recalled product is Actavis Metformin hydrochloride Extended-Release Tablets, 1000 mg, sold in 60-count bottles with NDC 00591-2720-60 and lot number 1410946A.
  2. Check the label on your prescription bottle for lot number 1410946A and an expiration date of 06/2023 to determine if your medication is part of this recall.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metformin hydrochloride Extended-Release Tablets, 1000 mg (60-count bottle)
Variants: 1000 mg, Extended-Release, 60-count
Lot Numbers:
1410946A (Exp. 06/2023)
NDC:
00591-2720-60

Recall #: D-0441-2023; Distributed by Actavis Pharma, Inc.; Manufactured by Actavis Laboratories FL, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91744
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 12,044 Bottles
Distributed To: California

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.