Zydus Pharmaceuticals recalls 25mg Chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding 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 25mg Chlorpromazine Hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if taken as directed. Affected products have specific lot numbers and expiration dates.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable intake limit. This chemical could potentially cause health issues when taken as prescribed. The hazard is related to the manufacturing process and not the product's intended use.
Prescription medication users who have the specific lot numbers listed in the recall. Patients taking this medication for psychiatric conditions are most at risk.
Check for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle' with the specific lot numbers: Z305060, Z305061, Z306323, Z401153, Z403015, Z403016, Z405591. The expiration dates range from August 31, 2025 to April 30, 2026.
Verify the product name, lot numbers, and expiration dates listed in the recall notice.
The recall notice states that the tablets may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. Patients should not use the recalled products and contact their healthcare provider for alternatives.
The recall notice does not specify a remedy, so you should check with your healthcare provider for guidance on safe alternatives.
Look for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle' with the specific lot numbers: Z305060, Z305061, Z306323, Z401153, Z403015, Z403016, Z405591 and expiration dates from August 31, 2025 to April 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-0632-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0632-2025 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.
