Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects 100-count bottles of 50 mg tablets due to excessive levels of N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and contact health providers for guidance.
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 recalled product is Chlorpromazine Hydrochloride Tablets, USP, available in 50 mg dosage. They are packaged in 100-count bottles. The lot numbers include Z306327, Z306748, Z401154, Z403738, and Z405645.
The recall stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable intake limits. This contamination could pose serious health risks to consumers.
There are no specific reports of injuries or deaths related to this recall. The contamination is classified as a Class II risk due to potential health impacts.
Consumers should stop using Chlorpromazine Hydrochloride Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further assistance.
For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0634-2025.
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