Class IIOngoing

Xelstrym (dextroamphetamine) transdermal system recall

FDA recall D-0055-2025 · initiated Oct 31, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Noven
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA nationwide.
Initiated: Oct 31, 2024
FDA report date: Nov 27, 2024

This recall is linked to a product we cover: Xelstrym →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0055-2025 ↗

← All drug recalls