D-0112-2025 Class II Terminated
FDA drug recall D-0112-2025 was initiated by Lannett Company Inc. on October 25, 2024 and is designated Class II. Reason for recall: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. The recall status is terminated (terminated June 27, 2025). Affected quantity: 1608 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- October 25, 2024
- Termination Date
- June 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1608 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 23274856A, Exp 04/30/2025