Class II

Drug Recall: 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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · August 20, 2025

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

Distribution

Product was distributed nationwide within the United States.

States Affected

NATIONWIDE

Quantity Affected

26,628 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0594-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.