Fingolimod Capsules — Class II drug recall D-0925-2023
Ongoing recall by Ascend Laboratories, LLC, reported 2023-07-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0925-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2023-07-11 |
| Classified | 2023-07-18 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,652 bottles |
| Reason classes | specification failure |
| NDC | 67877-0476, 67877-0476-14, 67877-0476-30, 67877-0476-32, 67877-0476-33, 67877-0476-56, 67877-0476-58 |
| Lot numbers | 22122841 |
| Expiration dates | 2025-08-20 |
Product
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Reason for recall
Failed Dissolution Specifications
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-0925-2023. 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.