FDAClass II · Drug · Recalled June 10, 2026

Niacin Extended-release Tablets recall — Lannett Company Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0584-2026
Brand: Lannett Company
Classification: Class II
Units affected: 3984 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Niacin Extended-release Tablets

Companies & origin

Recalling firm location: Seymour, IN, United States
Firm address: 1101 C Ave W, 47274-3342

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 25282724A, Exp. Date 2027/01
Distribution: Nationwide within the United States
Firm notified the public via: Letter
FDA event ID: 99107
Recall initiated: May 27, 2026
FDA classified: June 10, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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