CLASS II ONGOING Drug recall · Reported 27 Nov 2024 · FDA Enforcement Report
Xelstrym (dextroamphetamine) transdermal system recalled
Noven Pharmaceuticals is recalling Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30, distributed nationwide in the US. The recall was initiated on 31 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0055-2025
- FDA event ID
- 95701
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Xelstrym
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2024
- FDA classified
- 19 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 31 Oct 2024 | Recall initiated by company | |
| 19 Nov 2024 | Classified by FDA | +19 days |
| 27 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Which lots are affected?
Lot # 95598, Exp 02/28/25
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Noven Pharmaceuticals
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
Other Dextroamphetamine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Packaging Defects | Nationwide |
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 5 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Tablets USP, 10 mg recalled | Impax Laboratories | Potency & Assay | Nationwide |