Product: 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.
Reason for recall: CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.
Recall initiated: 20250807
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated