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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

SUN PHARMACEUTICAL INDUSTRIES INC: Riomet ER Oral Suspension Recalled for NDMA Impurity Contamination

Agency Publication Date: October 1, 2020
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Summary

Sun Pharmaceutical Industries Inc. has recalled 747 bottles of Riomet ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL, because a finished drug product tested positive for the NDMA impurity. This prescription medication is used to treat type 2 diabetes, and the recall affects 16-ounce bottles from a specific lot distributed across the country. Consumers should contact their healthcare provider or pharmacist immediately to discuss alternative treatments while they return the affected product.

Risk

The drug product contains N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. While NDMA is a common environmental contaminant found in water and foods, exposure to higher-than-acceptable levels over long periods of time may increase the risk of cancer.

What You Should Do

  1. Check your medication bottle for Riomet ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL in the 16 oz. size.
  2. Verify if your bottle belongs to the affected Lot # AB06381 with an expiration date of 10/2021 (NDC 10631-019-17).
  3. Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as the risk of stopping diabetes treatment may outweigh the risk of the impurity.
  4. Return any unused portions of the affected medication to your pharmacy for a refund.
  5. Contact Sun Pharmaceutical Industries Inc. at 1-800-406-7984 for further instructions on the recall process or to report any adverse events.
  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

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL (16 oz.)
Model:
NDC 10631-019-17
Lot Numbers:
AB06381 (Exp 10/2021)
Date Ranges: October 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86464
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 747 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.