FDA Drugs recall ·
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only… recall
- Recall number
- D-0599-2025
- Date
- (initiated August 11, 2025)
- Company / brand
- Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 8544 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Why was it recalled?
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
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 #: 25280726A, Exp. Date 03/2027
Distribution
Nationwide within 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-0599-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.