Lannett Company Inc.: Drug Recall

Recall #D-0112-2025 · 10/25/2024

Class II: Risk

Recall Details

Recall Number: D-0112-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Lannett Company Inc.
Status: Terminated
Date Initiated: 10/25/2024
Location: Seymour, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1608 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Lannett Company Inc.

Class II: Risk 10/10/2025

Failed Dissolution Specifications
Class II: Risk 08/19/2025

Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Class II: Risk 08/11/2025

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class III: Low Risk 11/09/2022

Failed Impurity/Degradation Specifications
Class III: Low Risk 11/09/2022

Failed Impurity/Degradation Specifications

View all recalls by Lannett Company Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.