The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distr
Recalled October 15, 2025 · FDA recall D-0010-2026 · The Harvard Drug Group LLC
Hazard
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit · FDA Class II
Units
1256 blister packs
Sold at
Nationwide
Description
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Product
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →