Class II Recall Issued for Rizatriptan Benzoate Tablets Due to Impurity Concerns

Ascend Laboratories LLC has voluntarily initiated a nationwide Class II recall of Rizatriptan Benzoate Tablets, USP, 5 mg (NDC 67877-261-18), a prescription medication used for the acute treatment of migraine. The recall impacts lots 23142117, 23142119, 23142122 (expiring May 2026), and 24142625 (expiring June 2027) that have been distributed in 18-unit dose tablet configurations. The drug, manufactured by Alkem Laboratories Ltd in India and distributed by Ascend Laboratories from Parsippany, NJ, has been removed from the market due to concerns regarding a chemical impurity.

According to the US Food and Drug Administration (FDA) Enforcement Report, the recall was prompted by the detection of N-nitroso-dimethyl-rizatriptan, a nitrosamine impurity found above the agency's acceptable daily intake (ADI) limit. Nitrosamines are known for their genotoxic potential, and prolonged exposure may pose a cancer risk. Although the recall was voluntary and initiated by the firm on July 9, 2025, it is being closely monitored by the FDA. The agency officially classified the event as a Class II recall on July 17, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Rizatriptan benzoate is a serotonin (5-HT1) receptor agonist commonly prescribed to relieve migraine attacks with or without aura in adults. It works by narrowing blood vessels in the brain, helping to reduce headache symptoms. Pharmacists should be aware of this recall to ensure affected lots are removed from inventory and patients are advised appropriately. No press release has been issued for this recall, and notification of consignees has occurred via multiple channels, including email, fax, and direct contact.