Niacin Extended-release Tablets — Class II drug recall D-0096-2026
Ongoing recall by Lannett Company Inc., reported 2025-10-29, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0096-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company Inc., Seymour, IN, United States |
| Recall initiated | 2025-10-10 |
| Classified | 2025-10-22 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 62175-0320, 62175-0320-43, 62175-0320-46, 62175-0322, 62175-0322-43, 62175-0322-46 |
| Lot numbers | 21264027A, 22266446A, 22266901A, 22267553A, 22267554A, 22267555A, 22267992A, 22267993A, 22267994A |
| Expiration dates | 2025-10-30, 2025-12-31, 2026-02-28, 2026-03-31, 2026-04-30, 2026-05-31 |
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 for recall
Failed Dissolution Specifications
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-0096-2026. 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.