Niacin Extended-release Tablets — Class II drug recall D-0584-2026
Ongoing recall by Lannett Company Inc., reported 2026-06-10, distributed nationwide. Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-h
| Recall number | D-0584-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company Inc., Seymour, IN, United States |
| Recall initiated | 2026-05-27 |
| Classified | 2026-06-10 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,984 bottles |
| Reason classes | specification failure |
| NDC | 62175-0320, 62175-0320-43, 62175-0320-46, 62175-0322, 62175-0322-43, 62175-0322-46 |
| Lot numbers | 2027/01, 25282724A |
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 for recall
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
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-0584-2026. 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.