WhichRecall
Class IIReported 2025-06-04

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

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

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Recall Number
D-0451-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-02-28
Reported
2025-06-04
Distribution
U.S. Nationwide
Code Info
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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