Glenmark Pharmaceuticals recalls 100-count chlorpromazine tablets (NDC 68462-861-01) for potential N-Nitroso-Desmethyl Chlorpromazine impurity exceeding FDA limits. Patients should consult their doctor.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Glenmark is recalling 100-count 10mg chlorpromazine tablets due to a chemical impurity found in the manufacturing process. This impurity could pose a risk to patients taking the medication.
The tablets contain N-Nitroso-Desmethyl Chlorpromazine (NNDCI), a chemical impurity that exceeds FDA safety limits. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
Patients prescribed chlorpromazine tablets by a doctor are affected. Those with specific medical conditions may be at higher risk.
Check for the 100-count 10mg chlorpromazine tablets with NDC 68462-861-01. The product was manufactured for Glenmark Pharmaceuticals in New Jersey, with specific lot numbers and expiration dates.
Look for the NDC number 68462-861-01 on the tablet packaging.
The recall states the tablets contain an impurity exceeding FDA limits, but the exact risk level is not specified. Patients should consult their doctor.
The recall does not provide specific action steps for consumers. Patients should contact their doctor for guidance.
The recall mentions lot numbers 17230132 (exp 12/2024) and 17230449 (exp 01/2025), but the record does not specify which lot numbers are affected.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0159-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0159-2025 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.
