FDA recall D-0599-2025

Lannett Company Inc. · Class II · drug

Product

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

Reason for recall

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Distribution

Nationwide within the USA

Key facts

Status: Completed
Initiation date: 2025-08-11
Report date: 2025-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2025