Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride tablets, 25 mg, 100-count bottles distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc. for
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 prescribed by healthcare providers and distributed nationally in the United States.
The recall is due to CGMP deviations and the presence of an impurity above acceptable intake limits, which could pose health risks with exposure.
This recall is not described as part of a broader industry pattern in the provided notice.
For patients currently using this medication, stopping therapy should be done under clinician guidance to avoid withdrawal or symptom recurrence.
FDA recall enforcement page for D-0632-2025 and the manufacturer communications
Refunds or replacements typically 4-6 weeks after submission
Keep bottle, packaging, receipts, and any recall notices; document dates, conversations, and actions taken
NDC: 70710-1130-1; 25 mg tablets; 100-count bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; Nationwide distribution in the USA; Recall date: 2025-09-03; Status: ACTIVE; Reason: CGMP Deviations: N-Nitroso Desmethyl Chlorpromazine above acceptable intake; Model numbers not specified.
No injuries or incidents have been reported.
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