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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 (Metformin Hydrochloride) Recalled for Microbial Contamination

Agency Publication Date: April 13, 2021
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Summary

Approximately 13,834 bottles of Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor are being recalled because of potential microbial contamination. Riomet is a prescription medication used to treat type 2 diabetes, and this recall affects the 16 fl. oz. (473 mL) bottles. Consumers should immediately contact their healthcare provider or pharmacist for guidance regarding their treatment and return any unused medication to the pharmacy for a refund.

Risk

The product may be contaminated with microbes, which could cause serious infections, particularly in patients with compromised immune systems. While no specific illnesses have been reported in this notice, using contaminated medication poses a significant health risk.

What You Should Do

  1. Check your medication to see if you have Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor in 16 fl. oz. (473 mL) bottles.
  2. Identify if your bottle matches NDC number 10631-206-02 and one of the following lot numbers and expiration dates: J190386A (Exp. 3/2021), X190354A (Exp. 3/2021), J190393A (Exp. 5/2021), A200035A (Exp. 6/2021), B200064A (Exp. 8/2021), or H200236A (Exp. 1/2022).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  4. Return any unused portions of the affected lots to the pharmacy where you purchased them to receive a refund.
  5. Contact Sun Pharmaceutical Industries Inc. at their Princeton, New Jersey office or through your dispensing pharmacy for additional instructions regarding the return process.
  6. For further questions about this recall, you can contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor (16 fl. oz.)
Model:
NDC 10631-206-02
Lot Numbers:
J190386A (Exp. 3/2021)
X190354A (Exp. 3/2021)
J190393A (Exp. 5/2021)
A200035A (Exp. 6/2021)
B200064A (Exp. 8/2021)
H200236A (Exp. 1/2022)
Date Ranges: Expiration March 2021, Expiration May 2021, Expiration June 2021, Expiration August 2021, Expiration January 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87650
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 13,834 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 · 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.