Zydus Pharmaceuticals recalls 100mg Chlorpromazine tablets due to potential presence of N-Nitroso Desmethyl Chlorpromazine above safe limits. Rx-only medication with specific lot numbers and expiration dates.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 100mg 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 could potentially cause health issues if consumed in quantities exceeding the acceptable limit.
People with prescriptions for this medication are affected. Those who have the specific lot numbers or expiration dates listed in the recall are most at risk.
Check for the specific lot numbers: Z305079, Z305080 (exp 09/25), Z305454, Z305455, Z305457, Z400492, Z400493, Z400494 (exp 12/25), Z401158, Z401725, Z401726 (exp 02/26), Z404118, Z404119, Z404120 (exp 06/26), Z405648 (exp 09/26).
Look for the specific lot numbers listed in the recall notice to determine if your tablets are affected.
The recall indicates potential unsafe levels of N-Nitroso Desmethyl Chlorpromazine, but the official notice does not specify if it's safe to take.
The recall notice does not provide specific instructions for what to do with the affected tablets.
Check the lot numbers on your tablets against the list provided in the recall notice: Z305079, Z305080 (exp 09/25), Z305454, Z305455, Z305457, Z400492, Z400493, Z400494 (exp 12/25), Z401158, Z401725, Z401726 (exp 02/26), Z404118, Z404119, Z404120 (exp 06/26), Z405648 (exp 09/26).
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0636-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0636-2025 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.
