FDA Drugs recall ·
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only… recall
- Recall number
- D-0584-2026
- Date
- (initiated May 27, 2026)
- Company / brand
- Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3984 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
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 #: 25282724A, Exp. Date 2027/01
Distribution
Nationwide within the United States
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-0584-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.