August 2025 FDA Recall Lisdexamfetamine Dimesylate by Lannett Company Inc.
D-0599-2025 - Labeling
This Class II drug recall was voluntarily initiated by Lannett Company Inc. on August 11, 2025 for the product Lisdexamfetamine Dimesylate. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0599-2025
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
08-11-2025
09-03-2025
8544 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lannett Company Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Batch or Lot Expiration Information
Lot# : 25280726A, Exp. Date 03/2027
