Zydus Lifesciences and Zydus Pharmaceuticals US recall Chlorpromazine Hydrochloride Tablets, 10 mg, 100-count bottles sold nationwide in the United States after detecting an impurity above acceptable intake. The impurity is N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and contact the manufacturer for guidance.
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 is an antipsychotic medication used to treat certain psychiatric conditions. The 10 mg tablets come in 100-count Rx bottles distributed in the U.S. by Zydus Pharmaceuticals USA.
An impurity, N-Nitroso Desmethyl Chlorpromazine, was detected at levels above the acceptable intake limit during CGMP testing. Long-term exposure carries potential health risks.
This recall is not described as part of a broader industry pattern.
Patients currently taking this medication may need medical guidance to discuss alternatives. No injuries have been reported to date; exposure to the impurity remains a safety concern.
FDA recall notice (D-0630-2025) and product labeling. See https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0630-2025
Refunds or replacements, if offered, typically take weeks after submission. Follow physician guidance.
Keep the recall notice, bottle label, NDC, lot numbers, and expiration dates. Record all communications with the manufacturer and pharmacy.
NDC 70710-1129-1; 100-count bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ; Sold nationwide in USA; Recall date 2025-09-03; FDA status Active; Lots Z403012 (Exp 30-04-2026) and Z406657 (Exp 30-11-2026)
No injuries or incidents have been reported.
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