Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects 25 mg tablets due to high levels of N-Nitroso Desmethyl Chlorpromazine. Consumers must stop using the product immediately.
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 Chlorpromazine Hydrochloride Tablets, USP, come in 100-count bottles. The affected lot numbers include Z305060, Z305061, Z306323, Z401153, Z403015, Z403016, and Z405591. They were distributed nationwide in the USA.
The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. This chemical is a potential carcinogen, posing serious health risks.
No injuries or incidents have been reported as a result of this recall. However, the potential health risks warrant immediate action.
Stop using the product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance on what to do next.
For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX or visit their website at www.zydus.com.
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