Why it was recalled
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Product description
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
Lot numbers, UPCs & expiration codes
Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0012-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 12, 2025
- FDA report date
- Oct 15, 2025
- Quantity
- 866 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0012-2026, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97584
- Address
- 341 Mason Rd
- Code information
- Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
- Postal code
- 37086-3606
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0012-2026
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 866 blister packs
- Reason for recall
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 12, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 7, 2025