Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride tablets on September 3, 2025. The recall affects tablets manufactured in India with high levels of a hazardous chemical. Consumers must stop using the product immediately and contact their healthcare provider.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
The recall involves Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles. The affected lot numbers include Z305079, Z305080, Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Z401158, Z401725, Z401726, Z404118, Z404119, Z404120, and Z405648. The expiration dates range from September 30, 2025, to June 30, 2026.
The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This chemical poses serious health risks and the FDA has classified this recall as Class II.
No specific incidents, injuries, or deaths have been reported related to this recall. However, the potential health risks warrant immediate consumer action.
Consumers should stop using the recalled tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.
For more information, contact Zydus Pharmaceuticals at 1-800-XXXX-XXXX or visit the FDA's website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0636-2025.
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