Chlorpromazine Hydrochloride Tablets Recalled for Manufacturing Deviation
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to manufacturing deviations resulting in excessive N-Nitroso Desmethyl Chlorpromazine impurity. Approximately 866 blister packs 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: FDA Class II recall involving N-Nitroso Desmethyl Chlorpromazine impurity above the recommended intake limit. N-nitroso compounds are regulated due to potential carcinogenic properties, representing a risk-of-harm product; however, no illnesses or injuries have been reported in the source.
Plain-English summary
Major Pharmaceuticals and Rugby Laboratories is recalling Chlorpromazine Hydrochloride Tablets, USP, 100 mg (NDC 0904-7132-61) distributed nationwide due to a current good manufacturing practice (CGMP) deviation that resulted in N-Nitroso Desmethyl Chlorpromazine levels above the recommended intake limit.
Approximately 866 blister packs are affected. The recalled lots are: N01920 (expiration date 12/31/2025), N02023 (expiration date 02/28/2026), and N02202 (expiration date 06/30/2026).
Patients currently taking this medication should consult their healthcare provider before making any changes to their treatment. Consumers who have affected lots should contact their pharmacy or healthcare provider for guidance on obtaining a replacement medication or alternative treatment.
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
- nitroso-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 (6)
- Lots N01920
- Exp. Date
- 12/31/2025
- N02023
- 02/28/2026 & N02202
- 06/30/2026
Distribution
Distributed nationwide across the United States.
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