Chlorpromazine Hydrochloride Tablets recalled for N-nitroso impurity
Major Pharmaceuticals is recalling chlorpromazine hydrochloride tablets due to N-nitroso desmethyl chlorpromazine impurity above recommended limits. Approximately 1,394 blister packs distributed nationwide are affected.
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 a Class II FDA recall involving a quality control deviation with an impurity above recommended limits. No illnesses or injuries have been reported, which caps the score at 3 per the rubric rule that limits theoretically harmful, unverified hazards to a maximum of High.
Plain-English summary
Major Pharmaceuticals, operating as The Harvard Drug Group LLC and Rugby Laboratories, is recalling chlorpromazine hydrochloride tablets, USP, 200 mg, supplied in 100-tablet blister packs. Three production lots are affected: N01928 (expires 09/30/2025), N02008 (expires 03/21/2026), and N02071 (expires 02/28/2026). Approximately 1,394 blister packs have been distributed.
The recall was issued due to a current good manufacturing practice (CGMP) deviation. Testing identified the presence of N-nitroso desmethyl chlorpromazine above the recommended intake limit in the affected lots.
The affected tablets were distributed nationwide. Patients currently taking chlorpromazine from the recalled lots should contact their healthcare provider or pharmacist to verify whether their medication is affected and to discuss appropriate next steps.
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
- n-nitroso-impurity
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 (6)
- Lots N01928
- Exp. Date
- 09/30/2025
- N02008
- 03/21/2026 & N02071
- Exp. Date 02/28/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORPROMAZINE HYDROCHLORIDE
- HighChlorpromazine Hydrochloride Tablets Recalled for Elevated N-Nitroso Impurity
FDA (Drugs) · 2025-10-15
- HighChlorpromazine Hydrochloride 25 mg Tablets Recalled for Chemical Impurity
FDA (Drugs) · 2025-10-15
- HighPrescription drug recall: Chlorpromazine hydrochloride tablets due to nitrosamine impurity
FDA (Drugs) · 2025-10-15
- HighChlorpromazine Hydrochloride Tablets Recalled for Manufacturing Deviation
FDA (Drugs) · 2025-10-15
- ModerateChlorpromazine Hydrochloride Tablets Recalled for Foreign Substance in Packaging Material
FDA (Drugs) · 2025-09-24
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27