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 500 mg Recalled by Lupin 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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
Quantity: 59,568 bottles
Why Was This Recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Where Was This Sold?
Product was distributed throughout the United States.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report