FDA Drugs recall ·
Xelstrym (dextroamphetamine) transdermal system… recall
Read the official FDA notice ↗
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
Why was it recalled?
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 95598, Exp 02/28/25
Distribution
USA nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0055-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.