Noven Pharmaceuticals Inc recalls Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal…

Recall date

October 31, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0055-2025

FDA classification

Class II

Brand / firm

Noven Pharmaceuticals Inc

Sold / distributed

USA nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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