Home / drug / D-0594-2025 Class II Reported 2025-08-27
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61 Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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Recall Number D-0594-2025
Classification Class II
Status Ongoing
Category drug
Initiated 2025-08-20
Reported 2025-08-27
Distribution Product was distributed nationwide within the United States.
Code Info Lot #: T05693, Exp. Date 03/2026 Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer .