Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The tablets exceed the acceptable limit for N-Nitroso Desmethyl Chlorpromazine. This recall affects the nationwide distribution in the USA.
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, 200 mg, 100-count bottle. Lot numbers include Z305083, Z305084, Z305468, Z305469, Z305470, Z401163, Z401165, Z402217, Z402218, Z405518, Z405520, Z406235. The expiration dates range from September 30, 2025, to October 31, 2026.
The recall was initiated due to CGMP deviations. The presence of N-Nitroso Desmethyl Chlorpromazine exceeds the recommended acceptable intake limit, posing potential health risks.
No specific injury or incident counts were reported. The high hazard level indicates a serious risk associated with contamination.
Stop using the recalled product immediately. Contact Zydus Pharmaceuticals or your healthcare provider for further guidance.
For more details, visit the FDA website or contact Zydus Pharmaceuticals (USA) Inc. at their office in Pennington, NJ.
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