Rizatriptan Benzoate Tablets recalled over manufacturing violations

Recall date

July 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…

Recall number

D-0533-2025

FDA classification

Class II

Brand / firm

Ascend Laboratories, LLC

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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