Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Riomet (metformin hydrochloride oral solution) Recalled by Sun Pharmaceutical Industries, Inc. Due to Labeling: Not Elsewhere Classified: Sun Pharma has decided...

Date: April 26, 2018
Company: Sun Pharmaceutical Industries, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sun Pharmaceutical Industries, Inc. directly.

Affected Products

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

Quantity: 19,758 473 mL bottles

Why Was This Recalled?

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report