Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured

Recalled February 12, 2025 · FDA recall D-0215-2025 · Glenmark Pharmaceuticals Inc., USA

Hazard

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

Sold at

Nationwide in the U.S

Description

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

Product

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.

Manufacturer(s)

Glenmark Pharmaceuticals Inc., USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →