FDA Drugs recall ·
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only… recall
- Recall number
- D-0096-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46,848 90-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0096-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.