FDA recall D-0584-2026

Lannett Company Inc. · Class II · drug

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 for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2026-05-27
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2026