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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

Granules Pharmaceuticals Inc: Metformin Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: July 14, 2020
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Summary

Granules Pharmaceuticals is recalling approximately 478,173 bottles of Metformin Hydrochloride Extended-Release Tablets (750 mg), a medication used to treat type 2 diabetes. The recall includes both 100-count and 500-count bottles that were distributed nationwide across the United States. This action was taken because FDA testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed the acceptable daily intake limit. Consumers should continue taking their medication until they speak with a healthcare provider, as stopping diabetes medication suddenly can pose serious health risks.

Risk

The tablets contain NDMA, a substance classified as a probable human carcinogen based on laboratory tests. While NDMA is a common environmental contaminant found in water and foods, long-term exposure to levels above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for Metformin Hydrochloride Extended-Release Tablets USP, 750 mg with NDC 70010-492-01 (100-count) or NDC 70010-492-05 (500-count).
  2. If you have a 100-count bottle, verify if your lot number and expiration date matches any of the following: 4920003A (May-21), 4920004A (Jun-21), 4920005A (Jun-21), 4920009A (Nov-21), 4920010A (May-22), 4920011A (Jun-22), 4920012A (Jun-22), 4920013A (Jul-22), 4920014A (Jul-22), 4920015A (Aug-22), or 4920016A (Jan-23).
  3. If you have a 500-count bottle, check for lot number 4920005B with an expiration date of Jun-21.
  4. Do NOT stop taking your medication without first consulting your doctor or pharmacist; stopping treatment for type 2 diabetes can lead to dangerous blood sugar spikes and serious health complications.
  5. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or an alternative treatment for your condition.
  6. Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund and contact Granules Pharmaceuticals Inc. for further instructions.
  7. For additional information or to report a concern, contact the FDA Consumer Complaint hotline 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-count bottle)
Model:
NDC 70010-492-01
Lot Numbers:
4920003A (Exp May-21)
4920004A (Exp Jun-21)
4920005A (Exp Jun-21)
4920009A (Exp Nov-21)
4920010A (Exp May-22)
4920011A (Exp Jun-22)
4920012A (Exp Jun-22)
4920013A (Exp Jul-22)
4920014A (Exp Jul-22)
4920015A (Exp Aug-22)
4920016A (Exp Jan-23)
Date Ranges: May 2021, June 2021, November 2021, May 2022, June 2022, July 2022, August 2022, January 2023
Product: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg (500-count bottle)
Model:
NDC 70010-492-05
Lot Numbers:
4920005B (Exp Jun-21)
Date Ranges: June 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85986
Status: Active
Manufacturer: Granules Pharmaceuticals Inc
Sold By: Pharmacies nationwide
Manufactured In: United States, India
Units Affected: a) 476,073 bottles; b) 2,100 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.