Major Pharmaceuticals recalls chlorpromazine tablets over impurity above the recommended limit
The tablets contain N-Nitroso Desmethyl Chlorpromazine, an impurity, at a level above the recommended intake limit, and the notice says the problem stems from manufacturing practice deviations.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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; Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals…
- Hazard
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Units
- 1394 blister packs; 506 blister packs; 1256 blister packs
- Where sold
- Nationwide
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 7, 2025
- Recall started
- September 12, 2025
- FDA enforcement report
- October 15, 2025
- Identifiers
- Codes: Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
- FDA recall number: D-0013-2026
- Codes: Lots N02009 & N02026, exp. date 02/28/2026
- FDA recall number: D-0011-2026
- Codes: Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
- FDA recall number: D-0010-2026
- Codes: Lots N01943 and Lot N02025, exp. date 02/28/2026
- FDA recall number: D-0009-2026
- Codes: Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
- FDA recall number: D-0012-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 | 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 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
- Reason for recall
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide
- Quantity
- 1394 blister packs; 506 blister packs; 1256 blister packs; 2064 blister packs; 866 blister packs
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