Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects 10 mg tablets sold nationwide due to contamination with N-Nitroso Desmethyl Chlorpromazine. Consumers should 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, 10 mg, sold in 100-count bottles. The affected lot numbers include Z403011 and Z407335 with expiration dates of April 30, 2026, and November 30, 2026, respectively.
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