Class IIOngoing

Rizatriptan Benzoate Tablets recall

FDA recall D-0533-2025 · initiated Jul 9, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Details

Product: Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Recalling company: Ascend Laboratories, Ltd
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Jul 9, 2025
FDA report date: Jul 23, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0533-2025 ↗

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