FDAClass III · Drug · Recall D-0533-2026 · Recalled May 27, 2026

Primidone Tablets USP recall — Lannett Company Inc.

Agency report date: May 27, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Primidone Tablets USP
Company / brand: Lannett Company
Lot / serial / date codes: 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

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class III: not likely to cause adverse health consequences.

Affected product: Primidone Tablets USP

3. Open the official notice or contact

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

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

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved August 25, 2026 at 6:00 PM UTC.

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