Why it was recalled
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Product description
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Lot numbers, UPCs & expiration codes
Lot: 23274856A, Exp 04/30/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0112-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 25, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 1608 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0112-2025, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 95630
- Address
- 1101 C Ave W
- Code information
- Lot: 23274856A, Exp 04/30/2025
- Postal code
- 47274-3342
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0112-2025
- Classification
- Class II
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 1608 bottles
- Termination date
- Jun 27, 2025
- Reason for recall
- Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2024