Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: La...
FDA Recall #D-0112-2025 — Class II — October 25, 2024
Product Description
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Reason for Recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Recalling Firm
Lannett Company Inc. — Seymour, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1608 bottles
Distribution
Nationwide in the USA
Code Information
Lot: 23274856A, Exp 04/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated