Recalls / Class II
Class IID-0112-2025
Product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
- 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: 23274856A, Exp 04/30/2025
Why it was recalled
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
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
- 1608 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-10-25
- FDA classified
- 2024-12-05
- Posted by FDA
- 2024-12-11
- Terminated
- 2025-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0112-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.