Glenmark Pharmaceuticals recalls 25mg chlorpromazine hydrochloride tablets (NDC 68462-862-01) due to N-Nitroso-Desmethyl Chlorpromazine impurity exceeding FDA limits. This is a prescription-only medication.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Glenmark is recalling 25mg chlorpromazine hydrochloride tablets (100-count bottles) because they contain an impurity that exceeds FDA safety limits. This is a prescription-only medication that could pose a health risk if taken.
The tablets contain N-Nitroso-Desmethyl Chlorpromazine (NNDCI) impurities at levels above the FDA's recommended safety limit. This impurity could potentially cause health risks when taken as prescribed.
Prescription patients who have the 25mg chlorpromazine hydrochloride tablets (NDC 68462-862-01) from Glenmark Pharmaceuticals. Those with a prescription for this medication are most at risk.
Check for the 25mg chlorpromazine hydrochloride tablets (100-count bottle) with NDC code 68462-862-01. The product was manufactured for Glenmark Pharmaceuticals in New Jersey and expires December 31, 2024.
Look for the NDC code 68462-862-01 on the product label to confirm it is recalled.
The recall is due to impurities exceeding FDA safety limits, so it is not safe to take as prescribed.
The official recall notice does not specify a remedy or how to obtain the recalled medication.
The recalled tablets expire December 31, 2024.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0160-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0160-2025 from Glenmark. 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.
