FDA Recall D-0055-2025

Noven Pharmaceuticals Inc · Miami, FL

Class II Ongoing 560 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot # 95598, Exp 02/28/25

Quantity: 685 boxes

Reason for recall

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

Recall record

Recall number: D-0055-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA nationwide.
Recall initiated: 2024-10-31
Classified by FDA Center: 2024-11-19
FDA published: 2024-11-27
Recalling firm: Noven Pharmaceuticals Inc
Firm location: Miami, FL

Drug identification

Brand name(s): XELSTRYM
Generic name(s): DEXTROAMPHETAMINE
Manufacturer(s): Noven Therapeutics, LLC
NDC(s): 68968-0205, 68968-0210, 68968-0215, 68968-0220
Route(s): TRANSDERMAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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