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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: December 14, 2017
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Summary

Sun Pharmaceutical Industries is recalling specific lots of Riomet (metformin hydrochloride) Oral Solution, a prescription medication used to treat type 2 diabetes. The recall involves the cherry-flavored 500 mg/5 mL strength in both 4 fl. oz. and 16 fl. oz. bottles. The medicine was found to have microbial contamination, which could lead to infections. Consumers should contact their doctor or pharmacist immediately for guidance on their treatment and return any remaining product to their pharmacy.

Risk

Microbial contamination in a non-sterile oral solution can cause serious infections, particularly in patients with weakened immune systems or those with diabetes who are already at a higher risk for complications. No specific injuries or illnesses have been reported for this recall, but the presence of microorganisms poses a health safety risk.

What You Should Do

  1. Check your bottle of Riomet (metformin hydrochloride) Oral Solution Cherry Flavored (500 mg/5 mL) for lot numbers 160031A or A160031B with an expiration date of 11/17.
  2. Identify the packaging: This recall affects both the 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) white HDPE bottles.
  3. If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription so your diabetes treatment is not interrupted.
  4. Return any unused or remaining product from the affected lots to the pharmacy where you purchased it for a refund.
  5. Contact Sun Pharmaceutical Industries, Inc. at the distributor address in Cranbury, NJ, or via their customer service channels if you have additional questions regarding the return process.
  6. For further information or to report a complaint, call 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

Return unused product to the pharmacy.

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 Cherry Flavored 500 mg/5 mL (4 fl. oz.)
Model:
NDC 10631-206-01
Lot Numbers:
160031A (Exp. 11/17)
A160031B (Exp. 11/17)
Date Ranges: November 2017
Product: Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg/5 mL (16 fl. oz.)
Model:
NDC 10631-206-02
Lot Numbers:
160031A (Exp. 11/17)
A160031B (Exp. 11/17)
Date Ranges: November 2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78217
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: Pharmacies
Manufactured In: United States
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.