Chlorpromazine hydrochloride tablets recalled for N-nitroso impurity above limits
Zydus Pharmaceuticals recalls specific lots of chlorpromazine hydrochloride 50-mg tablets due to the presence of N-nitroso desmethyl chlorpromazine above acceptable limits.
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 is an FDA Class II recall involving a potential carcinogenic impurity (N-nitroso compound) above acceptable limits. No illnesses, hospitalizations, or deaths have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling specific lots of Chlorpromazine Hydrochloride Tablets, USP, 50 mg (NDC 70710-1131-1), manufactured by Zydus Lifesciences Ltd. in Baddi, India. The affected lots are Z306327, Z306748, Z401154, Z403738, and Z405645, with expiration dates ranging from November 2025 to September 2026.
The recall was initiated due to a current Good Manufacturing Practice (CGMP) deviation. Testing identified the presence of N-nitroso desmethyl chlorpromazine above the FDA's recommended acceptable intake limit. This impurity was discovered during quality control measures.
The product was distributed nationwide in the United States. Patients currently taking chlorpromazine from the affected lots should contact their pharmacist or healthcare provider to discuss continued use or alternative treatment options. Do not stop taking medication without professional medical guidance.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- n-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 (9)
- Lot #: Z306327
- Exp Date 30-11-25
- Z306748
- Z401154
- Exp Date 28-02-26
- Z403738
- Exp Date 31-05-26
- Z405645
- Exp Date 30-09-26
UPCs (3)
- 0370710112912
- 0370710113216
- 0370710113018
Distribution
Distributed nationwide across the United States.
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