FDA recall D-0594-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · drug

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-08-20
Report date: 2025-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2025