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 3

FDA recall notice · announced November 27, 2024 · Noven Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Notes

Distribution: USA nationwide.
Lot/code information: Lot # 95598, Exp 02/28/25
Quantity: 685 boxes
Status: Ongoing
Products in this recall event:
- 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, M (D-0055-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.