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: detection of N-Nitrosodimethylamine (NDMA) impurity above...
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, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only 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 Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
Quantity: a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles
Why Was This Recalled?
CGMP Deviations: detection of 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