D-0584-2026 Class II Ongoing

Recalled by Lannett Company Inc. — Seymour, IN

Recall Details

Product Type
Drugs
Report Date
June 10, 2026
Initiation Date
May 27, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3984 bottles

Product Description

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 for Recall

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 25282724A, Exp. Date 2027/01