Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

Recall date

September 12, 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 Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and…

Recall number

D-0011-2026

FDA classification

Class II

Brand / firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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

What was recalled

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617