Zydus Pharmaceuticals recalls 25mg Chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safe levels. This prescription medication was manufactured in India and distributed in the US. Affected lots have specific expiration dates.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 25mg Chlorpromazine Hydrochloride tablets because they contain a chemical (N-Nitroso Desmethyl Chlorpromazine) that exceeds safe limits. This could pose a health risk with long-term use, though the recall does not indicate immediate danger for most users.
The tablets contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable limit. This chemical is a potential carcinogen that could cause health issues with prolonged use, though the risk is not immediate or severe for most users.
Prescription patients who received the specific lots of 25mg Chlorpromazine tablets from Zydus Lifesciences Ltd. in India. Those with medical conditions requiring this medication are most at risk due to potential long-term exposure.
Check for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle' on the label. Look for lot numbers Z305062 (exp 08/31), Z306324 (exp 11/30), or Z401151/Z401152 (exp 02/28).
Identify the lot number and expiration date on the tablet packaging to determine if it's affected.
Discuss with your healthcare provider if you have the affected lot numbers to determine next steps.
The recall indicates potential long-term health risks from the chemical, but it does not indicate immediate danger for most users.
Check the lot number and expiration date on the packaging. If affected, contact your doctor for guidance.
Look for lot numbers Z305062 (exp 08/31), Z306324 (exp 11/30), or Z401151/Z401152 (exp 02/28) on the 25mg Chlorpromazine tablets.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0633-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0633-2025 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.
