Medications & Supplements/Prescription Drugs

Xelstrym (dextroamphetamine) Patches Recalled for Adhesive Defects

Agency Publication Date: November 19, 2024

Summary

Noven Pharmaceuticals Inc. is recalling 685 boxes of Xelstrym (dextroamphetamine) transdermal systems, a prescription patch used to treat ADHD. This recall was initiated because the adhesive used in the patches does not meet quality specifications, which could affect how the medication is delivered. If you have health concerns about your medication, you should contact your healthcare provider or pharmacist.

Risk

A defect in the adhesive (known as cold flow) may prevent the patch from functioning as intended, potentially causing the patch to fail or deliver an incorrect amount of medication.

What You Should Do

This recall involves Xelstrym (dextroamphetamine) transdermal system patches (13.5 mg/9 hours) sold in 30-count cartons under NDC 68968-0215-3. The affected units are marked with Lot 95598 and an expiration date of 02/28/25.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Noven Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xelstrym (dextroamphetamine) transdermal system (13.5 mg/9 hours)

Variants: 30 individually sealed transdermal patches, 13.5 mg/9 hours, foil-sealed polypropylene tray, paper carton/box

Lot Numbers:

95598 (Exp 02/28/25)

NDC:

68968-0215-3

Recall #: D-0055-2025; Manufactured by Noven Pharmaceuticals, Inc. in Miami, FL.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95701

Status: Active

Manufacturer: Noven Pharmaceuticals Inc

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 685 boxes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Xelstrym (dextroamphetamine) transdermal system patches (13.5 mg/9 hours) sold in 30-count cartons under NDC 68968-0215-3. The affected units are marked with Lot 95598 and an expiration date of 02/28/25.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Noven Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xelstrym (dextroamphetamine) transdermal system (13.5 mg/9 hours)

Variants: 30 individually sealed transdermal patches, 13.5 mg/9 hours, foil-sealed polypropylene tray, paper carton/box

Lot Numbers:

95598 (Exp 02/28/25)

NDC:

68968-0215-3

Recall #: D-0055-2025; Manufactured by Noven Pharmaceuticals, Inc. in Miami, FL.