Product: Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
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