Lannett Company Inc. recalls Niacin Extended-release Tablets
- Recalling company
- Lannett Company Inc.
- 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
- Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 27, 2026
- Reported
- Jun 10, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 3984 bottles
- Lot / codes
- Lot #: 25282724A, Exp. Date 2027/01
- Company location
- Seymour, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0584-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0584-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.