Class II

Drug Recall: 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

Glenmark Pharmaceuticals Inc., USA · February 28, 2025

Reason for Recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

84,048 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0450-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.