Chlorpromazine Hydrochloride Tablets Recalled for Nitroso Contamination
Zydus Pharmaceuticals recalls Chlorpromazine Hydrochloride 200 mg tablets nationwide due to N-Nitroso Desmethyl Chlorpromazine exceeding recommended acceptable limits. No illnesses reported.
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 a genotoxic impurity (N-nitroso compound) that exceeds the agency's recommended acceptable intake limit. No illnesses reported, but the presence of this high-risk contaminant qualifies as a risk-of-harm scenario.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Chlorpromazine Hydrochloride Tablets, USP, 200 mg, distributed nationwide in the United States. The medication is manufactured by Zydus Lifesciences Ltd. in Baddi, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, New Jersey.
The recall affects multiple lot numbers: Z305083, Z305084, Z305468, Z305469, Z305470 (expiring 30-09-25); Z401163, Z401165 (expiring 28-02-26); Z402217, Z402218 (expiring 31-03-26); Z405518, Z405520 (expiring 31-08-26); and Z406235 (expiring 31-10-26).
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. The affected tablets contain N-Nitroso Desmethyl Chlorpromazine at levels exceeding the FDA's recommended acceptable intake limit. N-nitroso compounds are genotoxic substances that pose potential long-term health risks.
No illnesses or adverse events have been reported associated with this product. Patients taking this medication should consult with their healthcare provider or pharmacist if they believe their supply is from an affected lot.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Tablet
- Hazard
- nitroso-contamination
- 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 (17)
- Lot #: Z305083
- Z305084
- Z305468
- Z305469
- Z305470
- Exp Date 30-09-25
- Z401163
- Z401165
- Exp Date 28-02-26
- Z402217
- Z402218
- Exp Date 31-03-26
- Z405518
- Z405520
- Exp Date 31-08-26
- Z406235
- Exp Date 31-10-26
UPCs (3)
- 0370710112912
- 0370710113216
- 0370710113018
Distribution
Distributed nationwide across the United States.
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