Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett ...
FDA Recall #D-0599-2025 — Class II — August 11, 2025
Product Description
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.
Recalling Firm
Lannett Company Inc. — Seymour, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8544 bottles
Distribution
Nationwide within the USA
Code Information
Lot #: 25280726A, Exp. Date 03/2027
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated