Recalls / Class II
Class IID-0599-2025
Product
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
- Brand name
- Lisdexamfetamine Dimesylate
- Generic name
- Lisdexamfetamine Dimesylate
- Active ingredient
- Lisdexamfetamine Dimesylate
- Route
- Oral
- NDCs
- 0527-4661, 0527-4662, 0527-4663, 0527-4664, 0527-4665, 0527-4666, 0527-4667
- FDA application
- ANDA215802
- Affected lot / code info
- Lot #: 25280726A, Exp. Date 03/2027
Why it was recalled
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Recalling firm
- Firm
- Lannett Company Inc.
- Manufacturer
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 8544 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2025-08-11
- FDA classified
- 2025-08-25
- Posted by FDA
- 2025-09-03
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0599-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.