FDA recall D-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

Reason for recall

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

Distribution

USA nationwide.

Key facts

Status

Ongoing

Initiation date

2024-10-31

Report date

2024-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2025