FDA Drug recall D-0925-2023
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
- FDA Drug
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA by Ascend Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0925-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-11 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 67877-476-56 |
|---|---|
| ndc | 67877-476-33 |
| ndc | 67877-476-32 |
| ndc | 67877-476-14 |
| ndc | 67877-476-58 |
| ndc | 67877-476-30 |
| code_info | Lot 22122841, Exp August 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Ascend Laboratories
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FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
All Ascend Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0925-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.