Glenmark Pharmaceuticals recalls 100mg chlorpromazine hydrochloride tablets (NDC 68462-864-01) with a nitrosated impurity that may pose health risks. Affected lots 17232222 and 17232237 expire 10/31/2025.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Glenmark is recalling 100mg chlorpromazine hydrochloride tablets that contain a harmful impurity. This impurity could potentially cause health issues if taken by people who need medication.
The tablets contain N-Nitroso-Desmethyl Chlorpromazine, an impurity that exceeds safety limits. This impurity could potentially cause health issues if taken by people who need the medication.
People with a prescription for chlorpromazine hydrochloride tablets who received the recalled lots (17232222 and 17232237) from Glenmark. Those with a prescription for this medication are most at risk.
Check for the product name 'chlorpromazine hydrochloride tablets, USP 100 mg, Rx Only, 100 Tablets per bottle'. Look for lot numbers 17232222 or 17232237 on the packaging. The expiration date is 10/31/2025.
Verify the lot number on the packaging to see if it matches 17232222 or 17232237.
The recall is for tablets with a harmful impurity that may pose health risks. People with a prescription should not take these specific lots.
The recall does not specify a remedy, so contact your doctor or pharmacist for advice.
Check the lot number on the packaging; if it is 17232222 or 17232237, the product is recalled.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0309-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0309-2025 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.
