Lannett Company Inc.: Niacin Extended-release Tablets, Usp, 1,000 Mg, 90-count Bottles
Recall Summary Lannett Company is recalling Niacin Extended-release Tablets (1,000 mg, 90-count bottles) distributed nationwide because the medication failed to dissolve properly during stability testing, meaning it may not release the drug into the body as intended. The recall affects prescription niacin tablets distributed across all U.S. states and Washington, D.C. This is classified as a Class II recall, indicating a potential health hazard.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-27
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f1ab9d78-7f07-4409-9ac6-7766c7106bc6