FDA Drug recall D-0584-2026
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, N…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, N… by Lannett, citing failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0584-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-27 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Reason
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Identifiers
| ndc | 62175-320-46 |
|---|---|
| ndc | 62175-320-43 |
| ndc | 62175-322-46 |
| ndc | 62175-322-43 |
| code_info | Lot #: 25282724A, Exp. Date 2027/01 |
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-0584-2026%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.