Major ChlorproMAZINE Hydrochloride Tablets recall — Class II (D-0012-2026) · pharmaranks
Class IIOngoing
Major ChlorproMAZINE Hydrochloride Tablets recall
FDA recall D-0012-2026 · 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, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
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.