PlainRecalls
FDA Drug Moderate Class II Completed

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

Reported: September 3, 2025 Initiated: August 11, 2025 #D-0599-2025

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.

Details

Recalling Firm
Lannett Company Inc.
Units Affected
8544 bottles
Distribution
Nationwide within the USA
Location
Seymour, IN

Frequently Asked Questions

What product was recalled?
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37. Recalled by Lannett Company Inc.. Units affected: 8544 bottles.
Why was this product recalled?
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 3, 2025. Severity: Moderate. Recall number: D-0599-2025.