FDA recall D-0112-2025

Product

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Reason for recall

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2024-10-25

Report date

2024-12-11

Termination date

2025-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2025