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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
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 23, 2026 at 11:04 PM UTC.
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