Glenmark Pharmaceuticals recalls 5mg Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity exceeding FDA limits. Affected lots manufactured in India with specific NDC and expiration dates.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark is recalling 5mg Rizatriptan Benzoate tablets that contain an impurity exceeding FDA safety limits. This could pose a health risk if taken by users, though the exact risk level isn't specified in the recall.
The tablets contain an impurity called N-Nitroso Desmethyl Rizatriptan that exceeds the FDA's acceptable limits. This impurity could potentially cause health issues if the tablets are taken, though the exact risk is not clearly defined in the recall.
People who have the specific lot numbers of Rizatriptan Benzoate tablets (NDC 68462-465-99) manufactured in India with expiration dates 9/2024 or 9/2025 are affected. Those using these tablets for migraines may be at risk.
Check the product label for the NDC number 68462-465-99 and expiration dates of 9/2024 or 9/2025. The tablets are manufactured in India and sold under Glenmark Pharmaceuticals.
Look for the NDC number 68462-465-99 and expiration dates of 9/2024 or 9/2025 on the tablet packaging.
The recall is due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits.
The recall record does not specify a remedy, so check the product details and contact Glenmark Pharmaceuticals for further instructions.
Yes, the affected lots are 19233788 (expiring 9/2025) and 19224445 (expiring 9/2024).
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0532-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0532-2024 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.
