Zydus Pharmaceuticals recalls 200mg chlorpromazine tablets with N-Nitroso Desmethyl Chlorpromazine above safe limits. Rx-only medication from India distributed in US. Check NDC and lot numbers for affected batches.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 200mg chlorpromazine hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if taken as directed. The recall affects specific batches distributed in the US.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine above the acceptable limit. This chemical could cause health issues when taken as prescribed. The hazard is related to the manufacturing process in India.
Prescription medication users who have the specific batch numbers listed in the recall. Patients with mental health conditions requiring chlorpromazine are most at risk.
Check for NDC code 70710-1133-1 and lot numbers Z305083, Z305084, Z305468, Z305469, Z305470 (expiring 09/30/2025), Z401163, Z401165 (expiring 02/28/2026), Z402217, Z402218 (expiring 03/31/2026), Z405518, Z405520 (expiring 08/31/2026), Z406235 (expiring 10/31/2026).
Look for NDC 70710-1133-1 and specific lot numbers listed in the recall.
The recall indicates potential unsafe levels of N-Nitroso Desmethyl Chlorpromazine. Do not take these specific batches until the recall is resolved.
Check the NDC code 70710-1133-1 and lot numbers Z305083 through Z406235 as listed in the recall.
The recall does not specify a remedy. Contact Zydus Pharmaceuticals (USA) Inc for guidance on next steps.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0638-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0638-2025 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
