Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RIOMET ER (metformin hydrochloride for extended-release oral suspension) Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in...
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 ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
Quantity: 747 bottles
Why Was This Recalled?
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report