Zydus Pharmaceuticals recalls 10mg chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safe limits. Rx-only medication with specific NDC and lot numbers affected.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 10mg chlorpromazine hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if taken as directed, though the recall does not specify immediate harm to users.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable limit. This chemical could potentially cause health issues if the medication is taken as prescribed, though the exact risk level is not specified in the recall.
Prescription patients using the recalled 100-count bottle of chlorpromazine tablets. Those with the specific NDC number 16714-047-01 or lot numbers Z403011 (expiring April 2026) or Z407335 (expiring November 2026) are most at risk.
Check for the NDC number 16714-047-01 on the bottle label. Look for lot numbers Z403011 (expiring April 2026) or Z407335 (expiring November 2026). The product is a prescription-only medication.
Verify the NDC number (16714-047-01) and lot numbers (Z403011 or Z407335) on the bottle label.
The recall states the tablets may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine, but does not specify if current use poses immediate harm. Consult your doctor for guidance.
The recall does not provide specific disposal or return instructions. Check with your healthcare provider or the manufacturer for next steps.
Look for the NDC number 16714-047-01 and lot numbers Z403011 (expiring April 2026) or Z407335 (expiring November 2026) on the bottle label.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0631-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0631-2025 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.
