Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects tablets containing N-Nitroso Desmethyl Chlorpromazine above safe limits. 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
The recall involves Chlorpromazine Hydrochloride Tablets, USP, 25 mg, in 100-count bottles. This product was manufactured by Zydus Lifesciences Ltd. in Baddi, India and distributed nationwide in the USA. The affected lot numbers include Z305062, Z306324, Z401151, and Z401152.
The recall stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine exceeding the acceptable intake limit. This contamination poses a significant health risk to users.
No specific incidents or injuries have been reported related to this recall. However, the contamination raises concerns about potential long-term health effects.
Stop using Chlorpromazine Hydrochloride Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further instructions and possible alternatives.
For additional information, consumers can visit the FDA recall page or contact Zydus Pharmaceuticals.
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