Zydus Pharmaceuticals recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects a specific lot due to contamination with N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and seek guidance from 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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Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle. Manufactured by Zydus Lifesciences Ltd., Baddi, India, and distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. NDC: 70710-1129-1.
The recall results from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. This contamination poses serious health risks.
No specific incidents or injuries have been reported in relation to this recall. The contamination risk is significant enough to warrant immediate action.
Consumers should stop using Chlorpromazine Hydrochloride Tablets immediately. Contact Zydus Pharmaceuticals or a healthcare provider for further guidance.
For assistance, call Zydus Pharmaceuticals (USA) Inc. at 1-800-XXX-XXXX. Visit the FDA recall page for more information.
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