Rizatriptan Benzoate Orally Disintegrating Tablets — Class II drug recall D-0535-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-06-12, distributed nationwide. CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
| Recall number | D-0535-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-05-13 |
| Classified | 2024-06-04 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 13,296 cartons |
| Reason classes | cgmp, specification failure |
| NDC | 68462-0467, 68462-0467-06, 68462-0467-46, 68462-0467-74, 68462-0468, 68462-0468-06, 68462-0468-46, 68462-0468-74 |
| Lot numbers | 19223402, 19224858, 19232492 |
| Expiration dates | 2024-07, 2024-11, 2025-06 |
Product
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable 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-0535-2024. 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.