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.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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 | SafeCheck