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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

RemedyRepack Inc.: Metformin Hydrochloride Extended Release Recalled for NDMA Impurity

Agency Publication Date: October 26, 2020
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Summary

RemedyRepack Inc. is recalling 79 blister cards (30 count) of Metformin Hydrochloride Extended Release 750 mg, a prescription medication used to treat type 2 diabetes. The recall was initiated because testing detected N-Nitrosodimethylamine (NDMA) at levels higher than the acceptable daily intake set by the manufacturer. Consumers should not stop taking their medication without first consulting a healthcare provider, as the risk of untreated diabetes may outweigh the risk of exposure to the impurity.

Risk

The product contains N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen based on results from laboratory tests. Long-term exposure to levels above the acceptable intake limit could potentially increase the risk of cancer.

What You Should Do

  1. Check your medication packaging to see if it is Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, with NDC 70518-2480-00.
  2. Verify if your product matches one of the affected lot numbers and expiration dates: J0423350-121219 (Exp. 12/31/2020), J0434828-020320 (Exp. 02/28/2021), J0442511-031220 (Exp. 03/31/2021), J0448429-040920 (Exp. 04/30/2021), J0472499-081020 (Exp. 08/31/2021), or J0472532-081020 (Exp. 08/31/2021).
  3. Contact your healthcare provider or pharmacist immediately for guidance on a replacement or alternative treatment before you stop taking the recalled medication.
  4. Return any unused portions of the recalled medication to the pharmacy or place of purchase for a refund.
  5. Contact RemedyRepack Inc. for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and medical consultation

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 750 mg (30 count blister cards)
Model:
NDC 70518-2480-00
Recall #: D-0050-2021
Lot Numbers:
J0423350-121219 (Exp. 12/31/2020)
J0434828-020320 (Exp. 02/28/2021)
J0442511-031220 (Exp. 03/31/2021)
J0448429-040920 (Exp. 04/30/2021)
J0472499-081020 (Exp. 08/31/2021)
J0472532-081020 (Exp. 08/31/2021)
Date Ranges: 12/31/2020, 02/28/2021, 03/31/2021, 04/30/2021, 08/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86624
Status: Resolved
Manufacturer: RemedyRepack Inc.
Manufactured In: United States
Units Affected: 79/30 count 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.