Rizatriptan Benzoate Tablets — Class II drug recall D-0534-2025
Ongoing recall by Ascend Laboratories, LLC, reported 2025-07-23, distributed nationwide. CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable in
| Recall number | D-0534-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Bedminster, NJ, United States |
| Recall initiated | 2025-07-09 |
| Classified | 2025-07-17 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 67877-0261, 67877-0261-01, 67877-0261-05, 67877-0261-18, 67877-0261-25, 67877-0261-30, 67877-0262, 67877-0262-01, 67877-0262-05, 67877-0262-18, 67877-0262-25, 67877-0262-30 |
| Lot numbers | 22143653, 22143675, 22144528, 22144977, 23140257, 23140999, 23141900, 23142118, 23142120, 23142123, 23144563, 23144565, 24142623, 24142624, 24142626, 24143469 |
| Expiration dates | 2025-07-20, 2025-09-20, 2025-11-20, 2025-12-20, 2026-02-20, 2026-05-20, 2026-11-20, 2027-05-20, 2027-06-20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0534-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.