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

FDA recall notice · announced December 11, 2024 · Lannett

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 23274856A, Exp 04/30/2025
Quantity: 1608 bottles
Status: Terminated
Products in this recall event:
- Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37 (D-0112-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.