Zydus Pharmaceuticals recalls 200mg Chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine above safe levels. 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 200mg 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 specify immediate danger.
The tablets contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable intake limit. This chemical is a potential health risk with long-term use, though the recall does not indicate immediate harm.
People with a prescription for this medication who received the recalled tablets from Zydus Lifesciences Ltd. in India. Those using the medication for extended periods are most at risk.
Check for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle' with the NDC code 16714-051-01. Look for lot numbers Z305085 (expiring 09/30/2025) or Z401166/Z401167 (expiring 02/28/2026).
Identify the NDC code 16714-051-01 and lot numbers Z305085, Z401166, or Z401167 on the packaging.
The recall states the tablets contain a chemical above safe levels, but does not specify immediate danger. Long-term use may pose health risks.
Check for the NDC code 16714-051-01 and lot numbers Z305085 (expiring 09/30/2025), Z401166, or Z401167 (expiring 02/28/2026).
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to stop using the medication.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0639-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0639-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
