October 2024 FDA Recall Lisdexamfetamine Dimesylate by Lannett Company Inc.
D-0112-2025 - Failed Content Uniformity Specifications
This Class II drug recall was voluntarily initiated by Lannett Company Inc. on October 25, 2024 for the product Lisdexamfetamine Dimesylate. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0112-2025
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
10-25-2024
12-11-2024
1608 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.
Terminated
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 in the USA
06-27-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Batch or Lot Expiration Information
Lot# Lot: 23274856A, Exp 04/30/2025
