FDA Drug recall D-0096-2026
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 191…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 191… by Lannett, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0096-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 62175-320-46 |
|---|---|
| ndc | 62175-320-43 |
| ndc | 62175-322-46 |
| ndc | 62175-322-43 |
| code_info | Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Ex…Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2026%22
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