Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Time-Cap Labs Recalled by Marksans Pharma Limited 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 Marksans Pharma Limited directly.
Affected Products
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Quantity: 11279 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 Marksans Pharma Limited
Marksans Pharma Limited has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report