Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: L...
FDA Recall #D-0096-2026 — Class II — October 10, 2025
Product Description
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
Recalling Firm
Lannett Company Inc. — Seymour, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
46,848 90-count bottles
Distribution
Nationwide in the USA
Code Information
Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated