Drug FDA Class II Ongoing cGMP deviation

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 Published Aug 27, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.

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

Hazards

N-Nitroso Carvedilol Impurity-1 (NNCI) · primary

Affected products (1)

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

CARVEDILOL · 26,628 cartons

NDC: 0904-7305, 0904-7306, 0904-7307, 0904-7308, 0904-7305-61, 0904-7306-61, 0904-7307-61, 0904-7308-61

Code info: Lot #: T05693, Exp. Date 03/2026

Affected areas

Nationwide

Timeline

Initiated

Aug 20, 2025
Published

Aug 27, 2025

Recall number: D-0594-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.