Prescription drug recall: Chlorpromazine hydrochloride tablets due to nitrosamine impurity
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride 25 mg tablets nationwide due to manufacturing deviations that resulted in N-Nitroso Desmethyl Chlorpromazine levels 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: FDA Class II recall without reported hospitalizations, injuries, or deaths. The hazard is N-Nitroso Desmethyl Chlorpromazine, a nitrosamine impurity posing potential health risk, but with no documented harm to date. This fits the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Major Pharmaceuticals and Rugby Laboratories are recalling Chlorpromazine Hydrochloride 25 mg tablets (Major ChlorproMAZINE Hydrochloride Tablets, USP, Rx Only). The affected product has NDC 0904-7130-06 and comes in 5x10 blister packages. The recall affects 2,064 blister packs of Lots N01943 and N02025, which have an expiration date of 02/28/2026. This product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. N-Nitroso Desmethyl Chlorpromazine is a nitrosamine impurity.
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
- nitrosamine
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 (2)
- Lots N01943 and Lot N02025
- exp. date 02/28/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORPROMAZINE HYDROCHLORIDE
- HighChlorpromazine Hydrochloride Tablets recalled for N-nitroso impurity
FDA (Drugs) · 2025-10-15
- 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
- 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
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