D-0584-2026 Class II Ongoing
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