Lannett Company Inc.: Niacin Extended-release Tablets, Usp, 1,000 Mg, 90-count Bottles

Recall Summary Lannett Company is recalling niacin extended-release 1,000 mg tablets (90-count bottles) distributed nationwide because the medication failed to dissolve properly during stability testing, which could affect how the body absorbs the drug. This is a Class II recall, meaning the product could cause serious health consequences or adverse effects. The recall affects all U.S. states and Washington, D.C.

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/39839568-bc26-41d1-be21-b26da6085da9