Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Metformin Hydrochloride Extended-Release Tablets USP Recalled by Granules Pharmaceuticals Inc Due to CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity...
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 Granules Pharmaceuticals Inc directly.
Affected Products
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
Quantity: a) 476,073 bottles; b) 2,100 bottles
Why Was This Recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Granules Pharmaceuticals Inc
Granules Pharmaceuticals Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report