Recalls / Class II
Class IID-0010-2026
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
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 0904-7132, 0904-7129, 0904-7130, 0904-7131, 0904-7133
- FDA application
- ANDA213368
- Affected lot / code info
- Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
Why it was recalled
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 1256 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-09-12
- FDA classified
- 2025-10-07
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.