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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

Metformin 750 mg Extended Release Recalled for Excessive NDMA Levels

Agency Publication Date: January 11, 2022
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Summary

RemedyRepack Inc. has recalled Metformin 750 mg Extended Release, a prescription medication used for diabetes, because testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable daily intake limits. The recall involves 56 blister cards that were distributed to a single direct account in Pennsylvania. Consumers using this medication should not stop taking it without first consulting their healthcare provider, as the risk of untreated diabetes may outweigh the risk of the impurity.

Risk

NDMA is classified as a probable human carcinogen, and long-term exposure to levels above the safety limit may increase the risk of cancer. No injuries or illnesses have been reported in connection with this recall.

What You Should Do

  1. The recalled products are Metformin 750 mg Extended Release tablets (NDC 70518-2920-00) packaged in blister cards and distributed by RemedyRepack Inc.
  2. Check your medication packaging for lot numbers J0511265-021121 (expiration 02/28/2022), J0499451-122220 (expiration 01/31/2022), J0496563-120820 (expiration 12/31/2021), or J0495111-120120 (expiration 12/31/2021).
  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.

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 750 mg Extended Release
Variants: 750 mg, Extended Release
Lot Numbers:
J0511265-021121 (Exp 02/28/2022)
J0499451-122220 (Exp 01/31/2022)
J0496563-120820 (Exp 12/31/2021)
J0495111-120120 (Exp 12/31/2021)
NDC:
70518-2920-00

Recall #: D-0366-2022; Quantity: 56 Blister Cards

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89331
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Direct account in PA
Manufactured In: United States
Units Affected: 56 Blister Cards
Distributed To: Pennsylvania

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.