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Drug FDA Class II Ongoing Failed specifications

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

Noven Pharmaceuticals Inc Published Nov 27, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Noven Pharmaceuticals Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Coldflow Adhesive Specification · primary

Affected products (1)

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

XELSTRYM · 685 boxes

NDC: 68968-0205, 68968-0210, 68968-0215, 68968-0220, 68968-0205-1, 68968-0205-3, 68968-0210-1, 68968-0210-3, 68968-0215-1, 68968-0215-3, 68968-0220-1, 68968-0220-3
Lot codes: 95598
Code info: Lot # 95598, Exp 02/28/25

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 31, 2024
  2. Published
    Nov 27, 2024
Recall number
D-0055-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.