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.
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
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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 product contains N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This chemical is a potential carcinogen, posing serious health risks.
No specific incidents or injuries related to this recall have been reported. The recall was initiated due to CGMP deviations.
Stop using the recalled tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.
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.
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