Why it was recalled
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Product description
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
Lot numbers, UPCs & expiration codes
Lot # 95598, Exp 02/28/25
Where it was sold
USA nationwide.
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-0055-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 31, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 685 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0055-2025, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 95701
- Address
- 11960 Sw 144th St
- Code information
- Lot # 95598, Exp 02/28/25
- Postal code
- 33186-6109
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0055-2025
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 685 boxes
- Reason for recall
- Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Oct 31, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2024