Glenmark recalls 5mg orally dissolving rizatriptan tablets due to N-nitroso desmethyl rizatriptan impurity exceeding FDA limits. Affected lots manufactured in NJ, India. No remedy stated.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark is recalling 5mg orally dissolving rizatriptan tablets that contain an impurity exceeding FDA safety limits. This could pose a health risk if taken, but the recall doesn't specify a remedy.
The tablets contain an impurity called N-nitroso desmethyl rizatriptan that exceeds the FDA's acceptable limit. This impurity could potentially cause health issues if the medication is taken as intended.
People who own or use the recalled 5mg orally dissolving rizatriptan tablets from Glenmark. Those with medical conditions requiring frequent use of this medication may be at higher risk.
Check for the product name 'Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg' with 18 tablets (3 x 6 units). Look for lot numbers 19224857 (expiring 11/2024) or 19232493 (expiring 6/2025).
Verify the lot number and expiration date on the packaging to confirm if the product is affected.
The official recall notice does not state any remedy.
The impurity is N-nitroso desmethyl rizatriptan, which exceeds the FDA's acceptable limit.
Check for lot numbers 19224857 (expiring 11/2024) or 19232493 (expiring 6/2025) on the packaging.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0534-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0534-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
