Recalls / Class II
Class IID-0055-2025
Product
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
- Brand name
- Xelstrym
- Generic name
- Dextroamphetamine
- Active ingredient
- Dextroamphetamine
- Route
- Transdermal
- NDCs
- 68968-0205, 68968-0210, 68968-0215, 68968-0220
- FDA application
- NDA215401
- Affected lot / code info
- Lot # 95598, Exp 02/28/25
Why it was recalled
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Recalling firm
- Firm
- Noven Pharmaceuticals Inc
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 685 boxes
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-10-31
- FDA classified
- 2024-11-19
- Posted by FDA
- 2024-11-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0055-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.