Zydus Lifesciences Ltd. and Zydus Pharmaceuticals (USA) Inc. recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottles distributed nationwide in the United States. The recall stems from CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine to exceed the acceptable intake limit. Health care providers and patients should stop using the product and contact the manufacturer
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. It is distributed as a prescription drug and requires pharmacy verification.
N-Nitroso Desmethyl Chlorpromazine is a nitrosamine impurity. Exposure levels above the acceptable intake limit may pose health risks over time.
This recall is not described as part of a broader industry pattern.
Patients must stop using the affected product and seek medical guidance. The recall may require medical substitution and monitoring.
NDC is printed on the bottle label. Recall pages and the FDA enforcement report provide model lists and guidance.
No refunds are specified for prescription drug recalls. Substitutions or guidance will be provided by the manufacturer and clinicians; timelines vary.
Keep the product, packaging, recall notice, and any correspondence with the manufacturer or physician for records
Model numbers affected include Z305079, Z305080, Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Z401158, Z401725, Z401726, Z404118, Z404119, Z404120, Z405648. Sold nationwide in the USA as 100-count bottles of 100 mg chlorpromazine hydrochloride tablets. Sold as Rx only. NDC: 70710-1132-1. Manufacturer: Zydus Lifesciences Ltd. (Baddi, India). Distributed by Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ 08534). Recall date: 2025-09-03.
No injuries or incidents have been reported.
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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.