FDA Recall D-0533-2025

Ascend Laboratories, LLC · Bedminster, NJ

Class II Ongoing 309 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0533-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US Nationwide.
Recall initiated: 2025-07-09
Classified by FDA Center: 2025-07-17
FDA published: 2025-07-23
Recalling firm: Ascend Laboratories, LLC
Firm location: Bedminster, NJ

Drug identification

Brand name(s): RIZATRIPTAN BENZOATE
Generic name(s): RIZATRIPTAN BENZOATE
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-261, 67877-262
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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