Class IIOngoing

Major ChlorproMAZINE Hydrochloride Tablets recall

FDA recall D-0013-2026 · initiated Sep 12, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
Recalling company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide
Initiated: Sep 12, 2025
FDA report date: Oct 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0013-2026 ↗

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