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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

Nostrum Laboratories Inc: Metformin Hydrochloride ER Tablets Recalled for NDMA Impurity

Agency Publication Date: February 4, 2021
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Summary

Nostrum Laboratories Inc is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets (750 mg), a prescription medication used to manage blood sugar in adults with type 2 diabetes. The recall was initiated because testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit set by the FDA. Consumers should continue taking their medication until they speak with a doctor or pharmacist, as the risk of stopping diabetes treatment suddenly may outweigh the risk of exposure to the impurity.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer with long-term exposure above safety limits. While no immediate injuries or illnesses have been reported from this specific batch, the presence of this impurity at elevated levels represents a potential long-term health risk.

What You Should Do

  1. Locate your prescription bottle and check the label to see if it is Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, manufactured by Nostrum Laboratories, Inc.
  2. Check the bottle for NDC 29033-056-01 and Lot Number MET200601 with an expiration date of 07/2022.
  3. If your medication matches these details, contact your healthcare provider or pharmacist immediately to discuss a replacement or an alternative treatment option.
  4. Do not stop taking the medication without first consulting a healthcare professional, as stopping metformin abruptly can pose significant health risks to individuals with type 2 diabetes.
  5. Return any unused portions of the affected medication to your pharmacy for a refund and contact Nostrum Laboratories Inc at their Kansas City location for further guidance.
  6. For additional questions or to report adverse effects, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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, 750 mg (100 Tablets per bottle)
Model:
NDC: 29033-056-01
Recall #: D-0249-2021
Lot Numbers:
MET200601 (Exp 07/2022)
Date Ranges: Expiration: July 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87210
Status: Active
Manufacturer: Nostrum Laboratories Inc
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 7071 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.