Xelstrym (dextroamphetamine) transdermal system recall
FDA recall D-0055-2025 · initiated Oct 31, 2024
Noven Pharmaceuticals Inc recalled Xelstrym (dextroamphetamine) transdermal system in Oct 2024 — an FDA Class II recall (D-0055-2025) because Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
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).
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 685 boxes
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 →
Frequently asked
- Was Xelstrym (dextroamphetamine) transdermal system recalled?
- Noven Pharmaceuticals Inc recalled Xelstrym (dextroamphetamine) transdermal system in Oct 2024 — an FDA Class II recall (D-0055-2025) because Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Xelstrym (dextroamphetamine) transdermal system recalled?
- Per the FDA enforcement record, the reason for recall D-0055-2025 was: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- Is a recalled Xelstrym (dextroamphetamine) transdermal system dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Xelstrym (dextroamphetamine) transdermal system are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # 95598, Exp 02/28/25. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0055-2025.