Zydus Pharmaceuticals recalls 50mg chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safety limits. Affected lots from India and US distribution.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 50mg chlorpromazine hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if consumed in amounts exceeding the acceptable limit.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the recommended safe intake. This chemical is a potential carcinogen that could increase cancer risk with long-term exposure.
Prescription patients using the recalled 50mg chlorpromazine tablets from Zydus Lifesciences Ltd. in India. Those with specific medical conditions requiring antipsychotic medication may be at higher risk.
Check for the NDC code 70710-1131-1 on the bottle. The product was manufactured by Zydus Lifesciences Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in New Jersey.
Look for the NDC code 70710-1131-1 on the bottle label.
The recall indicates potential unsafe levels of N-Nitroso Desmethyl Chlorpromazine, so it is not safe to use without checking the recall status.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
Check for the NDC code 70710-1131-1 on the bottle label.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0634-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0634-2025 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.
