Class IIReported 2025-06-04
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
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Recall NumberD-0450-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-02-28Reported2025-06-04DistributionU.S. NationwideCode InfoLot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.