Home / Recalls / Ascend Laboratories, LLC / D-0533-2025

D-0533-2025 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Bedminster, NJ

Recall Details

Product Type
Drugs
Report Date
July 23, 2025
Initiation Date
July 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide.

Code Information

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

Other recalls by Ascend Laboratories, LLC

  • D-0017-2026 Class II — Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-5 (September 19, 2025)
  • D-0018-2026 Class II — Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-9 (September 19, 2025)
  • D-0020-2026 Class II — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90) (September 19, 2025)
  • D-0019-2026 Class II — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90) (September 19, 2025)
  • D-0645-2025 Class II — Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Al (August 28, 2025)
  • D-0576-2025 Class II — Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx On (July 21, 2025)
  • D-0534-2025 Class II — Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, M (July 9, 2025)
  • D-0469-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx On (May 23, 2025)
  • D-0468-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx On (May 23, 2025)
  • D-0129-2025 Class II — Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by (December 12, 2024)