Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Carvedilol Tablets Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol...
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 Glenmark Pharmaceuticals Inc., USA directly.
Affected Products
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Quantity: 44,328 bottles
Why Was This Recalled?
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report