FDA Drugs recall ·
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle… recall
- Recall number
- D-0112-2025
- Date
- (initiated October 25, 2024)
- Company / brand
- Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 1608 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Why was it recalled?
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 23274856A, Exp 04/30/2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0112-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.