Class IIReported 2025-07-23

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

Reason for Recall

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

Recall Number

D-0534-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-09

Reported

2025-07-23

Distribution

US Nationwide.

Code Info

Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142623, Exp Date: May 2027; Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.