Lisdexamfetamine Dimesylate Capsule
FDA Recall NDC 0527-4663
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Lisdexamfetamine Dimesylate (NDC 0527-4663). A significant event, classified as Class II, was initiated on Aug 11, 2025 by Lannett Company, Inc.. The reported reason for this action was: "Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Aug 11, 2025
Sep 03, 2025
8544 bottles
Recall Profile & Regulatory Data
Event ID
97397
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Product Description
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
Affected Packages Involved in this Recall
0527-4661-37Product
0527-4662-37Product
0527-4663-37Product
0527-4664-37Product
0527-4665-37Product
0527-4666-37Product
0527-4667-37Product
Class II Terminated
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Oct 25, 2024
Dec 11, 2024
1608 bottles
Recall Profile & Regulatory Data
Event ID
95630
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 27, 2025
Product Description
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
Affected Packages Involved in this Recall
0527-4661-37Product
0527-4662-37Product
0527-4663-37Product
0527-4664-37Product
0527-4665-37Product
0527-4666-37Product
0527-4667-37Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
