Chlorpromazine 200 mg tablets recalled over nitrosamine impurity above acceptable intake
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable 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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the recommended acceptable intake limit is a potential harm and no injuries are reported.
Plain-English summary
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in 100-count bottles and available on prescription only, manufactured by Zydus Lifesciences Ltd. in Baddi, India for Northstar Rx LLC of Memphis, Tennessee, NDC 16714-051-01, are being recalled. Affected lots are Z305085 expiring 30-09-25 and Z401166 and Z401167 expiring 28-02-26. Distribution was nationwide.
The recall follows current good manufacturing practice deviations: the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Central Nervous System
- Hazard
- nitrosamine-impurity
- cgmp-deviation
- prescription-drug
- class-ii
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 (5)
- Lot #: Z305085
- Exp Date 30-09-25
- Z401166
- Z401167
- Exp Date 28-02-26
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2025-10-15
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