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Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),

Recalled June 4, 2025 · FDA recall D-0448-2025 · Glenmark Pharmaceuticals Inc., USA

Hazard
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit · FDA Class II
Units
[100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Sold at
U.S. Nationwide

Description

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

Product
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA

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

Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), | RecallWatchUSA