Zydus Lifesciences Recalls Chlorpromazine Tablets Due to Hazard
Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The tablets contain N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and consult healthcare providers.
Product Details
The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, sold in 100-count bottles. The affected lot numbers are Z306326 and Z401155, with expiration dates of November 30, 2025, and February 28, 2026, respectively.
The Hazard
The product contains N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This chemical is a potential carcinogen, posing serious health risks.
Reported Incidents
No specific incidents or injuries related to this recall have been reported. The recall was initiated due to CGMP deviations.
What to Do
Stop using the recalled tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.
Contact Information
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0635-2025 or contact Zydus Pharmaceuticals.