Ascend Laboratories recalls 10mg Rizatriptan Benzoate Tablets with N-nitroso-dimethyl-rizatriptan impurity above FDA limits. Affected lots from India manufacturing, distributed in US. No remedy stated in recall notice.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Ascend Laboratories is recalling 10mg Rizatriptan Benzoate Tablets that contain an impurity above FDA safety limits. This could pose a health risk if taken as prescribed. The recall affects specific production lots sold in the US.
The tablets contain N-nitroso-dimethyl-rizatriptan impurities at levels exceeding the FDA's acceptable intake limit. This impurity could potentially cause health issues if the medication is taken as directed.
Prescription users of the 10mg Rizatriptan Benzoate Tablets in the US. Those with the specific lot numbers listed in the recall notice are most at risk.
Check the product label for the lot numbers listed: 22143653, 22143675, 22144528, 22144977, 23140257, 23140999, 23141900, 23142118, 23142120, 23142123, 23144563, 23144565, 24142623, 24142624, 24142626, 24143469. The tablets are prescription-only and sold in the US.
Look for the lot numbers listed in the recall notice on the product packaging.
The recall notice states the tablets contain an impurity above FDA limits, but no specific safety advice is provided. Consult your healthcare provider for guidance.
Check the product label for the specific lot numbers listed in the recall notice: 22143653, 22143675, 22144528, 22144977, 23140257, 23140999, 23141900, 23142118, 23142120, 23142123, 23144563, 23144565, 24142623, 24142624, 24142626, 24143469.
The recall notice does not specify a remedy, so contact your healthcare provider for advice on whether to stop using the medication.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0534-2025 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0534-2025 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.
