FDA recall D-0096-2026

Product

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-10-10

Report date

2025-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2026