D-0533-2026 Class III Ongoing

Recalled by Lannett Company Inc. — Seymour, IN

Recall Details

Product Type
Drugs
Report Date
May 27, 2026
Initiation Date
April 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44865 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

USA Nationwide

Code Information

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.