Chlorpromazine Hydrochloride 25 mg Tablets Recalled for Chemical Impurity
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride 25 mg tablets nationwide due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a detected manufacturing deviation resulting in a chemical impurity above recommended limits, but no illnesses or injuries have been reported. The hazard is theoretical and risk-based rather than connected to documented harm.
Plain-English summary
Major Pharmaceuticals and Rugby Laboratories (operating as The Harvard Drug Group LLC) is recalling Chlorpromazine Hydrochloride 25 mg tablets in blister packs due to a Current Good Manufacturing Practice (CGMP) deviation. The recalled product includes Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, distributed nationwide.
The recall was initiated because testing detected the presence of N-Nitroso Desmethyl Chlorpromazine at levels above the recommended intake limit. This chemical impurity resulted from a manufacturing process deviation.
The affected lots are N01954 (with expiration date 11/30/2025) and N02024 (with expiration date 02/28/2026). Patients currently taking these tablets should contact their healthcare provider or pharmacist for guidance. Pharmacies and healthcare providers should stop dispensing the recalled product and contact their suppliers for return instructions.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug
- Hazard
- chemical-impurity
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots N01954
- Exp. Date
- 11/30/2025 & N02024
- 02/28/2026
Distribution
Distributed nationwide across the United States.
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