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FDAFDA · Food and drugs·Recall number D-0535-2026

Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01

Published May 27, 2026 · Recall initiated: April 27, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
PRIMIDONE
Manufacturer
Golden State Medical Supply Inc.
Distributor
USA Nationwide
Lot
Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Risk classification
Class III
Area (FDA)
drug
Country
United States

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