Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects tablets with NDC 16714-051-01 due to N-Nitroso Desmethyl Chlorpromazine exceeding acceptable 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, 200 mg, in 100-count bottles. Lot numbers include Z305085, Z401166, and Z401167, with expiration dates of September 30, 2025, and February 28, 2026. The product was distributed nationwide across the USA.
The recall stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This contaminant poses a significant health risk.
Currently, there have been no reported injuries or incidents associated with this recall. However, the contamination risk is classified as high.
Stop using the recalled Chlorpromazine Hydrochloride Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.
For more information, consumers can visit the FDA's recall page or contact Zydus Pharmaceuticals (USA) Inc directly.
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