Class II

Drug Recall: Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Glenmark Pharmaceuticals Inc., USA · January 22, 2025

Reason for Recall

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Distribution

Nationwide in the U.S

States Affected

NATIONWIDE

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0215-2025

Status: ongoing

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