Carvedilol Tablets USP recalled over manufacturing violations

Recall date

August 20, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmace…

Recall number

D-0594-2025

FDA classification

Class II

Brand / firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold / distributed

Product was distributed nationwide within the United States.

Why it was recalled

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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