Lannett Company Inc. recalls Primidone Tablets USP
- Recalling company
- Lannett Company Inc.
- Product
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Reason
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Apr 24, 2026
- Reported
- May 27, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 44865 bottles
- Lot / 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.
- Company location
- Seymour, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0533-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0533-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.