Drug Recall: 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, Ma
Glenmark Pharmaceuticals Inc., USA · August 7, 2025
Reason for Recall
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Product Description
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
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
6,432 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0578-2025
Status: ongoing
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