Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Recall Number: D-0216-2025

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20250212

Initiation Date: 20250122

Termination Date:

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

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.