FDAHealthApril 24, 2026
Lannett Company Inc. — Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
⚠️ Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 24, 2026
USA Nationwide
What's affected?
- Product
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Brand
- PRIMIDONE
- UPC
- 0305871231011
- Lot code
- 25283038A
Additional details
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.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 44865 bottles.
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