FDA recall D-0533-2026

Lannett Company Inc. · Class III · drug

Product

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

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-04-24
Report date
2026-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2026