Zydus Pharmaceuticals recalls 100mg chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safe limits. Affected lots manufactured in India with specific 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 taken as directed. The recall applies to specific production lots with known expiration dates.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable safety limit. This chemical is a potential carcinogen that could cause health risks with long-term use or in specific medical conditions.
People who have the specific 100-count bottle of 100mg chlorpromazine tablets with the listed lot numbers and expiration dates. Prescriptions for this medication are typically for medical conditions requiring antipsychotic treatment.
Check for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle' with the lot numbers Z305456 (exp 10/31/2025), Z401156 (exp 02/28/2026), or Z407306 (exp 11/30/2026).
Verify the lot number and expiration date on the bottle to confirm if it's affected.
The recall is due to potential presence of N-Nitroso Desmethyl Chlorpromazine above the recommended safe limit, which could pose health risks.
The official recall notice does not specify a remedy or action for affected products.
Yes, affected lots have expiration dates: Z305456 expires 10/31/2025, Z401156 expires 02/28/2026, and Z407306 expires 11/30/2026.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0637-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0637-2025 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.
