FDAFDA · Food and drugs·Recall number D-0533-2026
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Published May 27, 2026 · Recall initiated: April 24, 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
- Lannett Company Inc.
- Distributor
- USA Nationwide
- UPC
- 0305871231011
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.