Why it was recalled
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Product description
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Lot numbers, UPCs & expiration codes
Lot #: 25280726A, Exp. Date 03/2027
Where it was sold
Nationwide within 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-0599-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 11, 2025
- FDA report date
- Sep 3, 2025
- Quantity
- 8544 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0599-2025, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 97397
- Address
- 1101 C Ave W
- Code information
- Lot #: 25280726A, Exp. Date 03/2027
- Postal code
- 47274-3342
- Report date
- Sep 3, 2025
- Product type
- Drugs
- Recall number
- D-0599-2025
- Classification
- Class II
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 8544 bottles
- Termination date
- Jun 24, 2026
- Reason for recall
- Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Aug 11, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2025