US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 25, 2024 (2 years ago)

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Lannett Company Inc.
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0112-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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