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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 Extended-Release Recalled for High NDMA Levels

Agency Publication Date: January 14, 2021
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Summary

Nostrum Laboratories Inc. is recalling 6,958 bottles of Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, a prescription drug used to manage blood sugar in adults with type 2 diabetes. The recall was initiated because the product contains N-Nitrosodimethylamine (NDMA) at levels that exceed the acceptable daily intake limit. These tablets are sold in 100-count white plastic bottles with NDC number 29033-056-01. Consumers should consult their doctor or pharmacist immediately for an alternative treatment, as it could be dangerous to stop taking this medication without a replacement.

Risk

The tablets contain a impurity called NDMA, which is classified as a probable human carcinogen based on laboratory tests. Long-term exposure to levels above the acceptable limit may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle label for the product name 'Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg' and NDC number 29033-056-01.
  2. Locate the lot number and expiration date on the bottle to see if it matches lot MET200501 with an expiration date of 07/2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the recalled medication.
  4. Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
  5. Contact Nostrum Laboratories, Inc. at 1-888-723-3332 for further instructions regarding this recall.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy 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: Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg (100 tablets per bottle)
Model:
NDC: 29033-056-01
Recall #: D-0227-2021
Lot Numbers:
MET200501 (Exp 07/2022)
Date Ranges: 07/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87080
Status: Active
Manufacturer: Nostrum Laboratories Inc
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 6958 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.