FDAClass III · Drug · Recalled May 27, 2026

Primidone Tablets USP recall — Lannett Company Inc.

Hazard: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0533-2026
Brand: Lannett Company
Classification: Class III
Units affected: 44865 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Affected products

Primidone Tablets USP

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#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Distribution: USA Nationwide
Firm notified the public via: Letter
FDA event ID: 98791
Recall initiated: April 24, 2026
FDA classified: May 18, 2026
FDA report date: May 27, 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.

Report a data error on this page