FDAClass IIDecember 11, 2024

Lisdexamfetamine Dimesylate Capsules recall

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

Why was Lisdexamfetamine Dimesylate Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 23274856A, Exp 04/30/2025

Product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Recalling firm
Lannett Company Inc.
Quantity
1608 bottles
Distribution
Nationwide in the USA
Recall date
December 11, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls