Chlorpromazine Hydrochloride Tablets Recalled for Elevated N-Nitroso Impurity
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride 50 mg tablets nationwide due to presence of N-Nitroso Desmethyl Chlorpromazine above recommended intake limits, affecting 506 blister packs (lots N02009 and N02026).
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 FDA Class II recall involves a manufacturing quality deviation where an impurity exceeded recommended intake limits. Per the severity rubric, since no illnesses or injuries have been reported and this represents a risk-of-harm scenario rather than documented injury, a High severity rating applies.
Plain-English summary
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets, USP, 50 mg due to presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. This represents a Current Good Manufacturing Practice (CGMP) deviation.
The recall affects 506 blister packs with lot numbers N02009 and N02026, expiring February 28, 2026, distributed nationwide by Major Pharmaceuticals in Indianapolis, Indiana (NDC 0904-7131-61).
Patients should not stop taking this medication without consulting their healthcare provider. If you have this product, contact your pharmacy or healthcare provider for instructions. Healthcare providers should check their inventory and notify affected patients if applicable.
N-Nitroso Desmethyl Chlorpromazine is an impurity with potential health risks when present above safe intake levels. The FDA is monitoring this recall.
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
- impurity
- manufacturing-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 (2)
- Lots N02009 & N02026
- exp. date 02/28/2026
UPCs (1)
- 003090471316
Distribution
Distributed nationwide across the United States.
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