Zydus Pharmaceuticals recalls 10mg chlorpromazine tablets due to potential impurity levels exceeding safety limits. Affected lots manufactured in India with specific NDC and expiration date.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Zydus Pharmaceuticals is recalling 10mg chlorpromazine hydrochloride tablets that may contain an impurity exceeding safe levels. This could pose a health risk if taken by patients.
The tablets may contain N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended safety limit. This impurity could potentially cause health issues if the medication is taken as directed.
Patients prescribed chlorpromazine by a healthcare provider. Those with the specific lot number and NDC 70710-1129-1 are most at risk.
Check for the product name 'chlorpromazine hydrochloride tablets 10mg', NDC 70710-1129-1, and lot number Z400069. The expiration date is December 31, 2025.
Identify the NDC number 70710-1129-1 and lot number Z400069 on the product label.
No, only specific lots with NDC 70710-1129-1 and lot number Z400069.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
The product was manufactured by Zydus Lifesciences Ltd. in Baddi, India.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0361-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0361-2025 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.
