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Drug FDA Class II Ongoing cGMP deviation

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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Oct 15, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

N-Nitroso Desmethyl Chlorpromazine · primary

Affected products (1)

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

CHLORPROMAZINE HYDROCHLORIDE · 1394 blister packs

NDC: 0904-7132, 0904-7129, 0904-7130, 0904-7131, 0904-7133, 0904-7129-61, 0904-7130-61, 0904-7130-06, 0904-7131-61, 0904-7132-61, 0904-7133-61, 0030904713
Lot codes: N01928
Code info: Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 12, 2025
  2. Published
    Oct 15, 2025
Recall number
D-0013-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.