Ascend Laboratories recalls 5mg rizatriptan tablets due to potential N-nitroso-dimethyl-rizatriptan impurity above FDA limits. Affected lots manufactured in India, distributed in US. No remedy specified.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Ascend Laboratories is recalling 5mg rizatriptan benzoate tablets that may contain an impurity exceeding FDA safety limits. This could pose a health risk if taken, but the recall does not include a specific action for consumers.
The tablets may contain N-nitroso-dimethyl-rizatriptan impurities at levels above the FDA's acceptable intake limit. This impurity could potentially cause health issues if the medication is taken as directed.
Prescription users of the 5mg rizatriptan benzoate tablets with NDC 67877-261-18. People who have the specific lots manufactured in India and distributed by Ascend Laboratories in the US are most at risk.
Check for the NDC number 67877-261-18 on the tablet packaging. Look for specific lots: 23142117, 23142119, 23142122 (expiring May 2026) or 24142625 (expiring June 2027).
Verify the NDC number 67877-261-18 and lot numbers listed above to confirm if your tablets are affected.
The tablets may contain N-nitroso-dimethyl-rizatriptan impurities above the FDA's acceptable intake limit.
The recall does not specify a remedy, so check the product details to confirm if your tablets are affected.
Yes, avoid lots 23142117, 23142119, 23142122 (expiring May 2026) and lot 24142625 (expiring June 2027).
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0533-2025 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0533-2025 from Ascend Laboratories. 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.
