Drug recall
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company…
FDA recall event 99107 · Class II · Lannett Company Inc.
Key facts
| Event ID | 99107 |
|---|---|
| Recall numbers | D-0584-2026 |
| Recalling firm | Lannett Company Inc. |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. |
| Initiation date | May 27, 2026 |
| Report date | Jun 10, 2026 |
| City | Seymour |
| State | IN |
| Country | United States |
| FEI number | 1819171 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: