Medications & Supplements/Prescription Drugs

Noven Pharmaceuticals, Inc.: Daytrana (methylphenidate) Transdermal Patches Recalled for Adhesive Failure

Agency Publication Date: April 13, 2018

Summary

Noven Pharmaceuticals is recalling 9,016 boxes of Daytrana (methylphenidate transdermal system) patches because the delivery system is defective. The adhesive on the patches was found to be out of specification, which can cause the medication to transfer incorrectly or the patch to fail to stay in place. This recall affects the 10 mg dosage (1.1 mg/hr) distributed nationwide in boxes of 30 patches.

Risk

The defective adhesive system can lead to improper drug delivery, potentially resulting in the patient receiving an incorrect dose of medication or the patch detaching from the skin prematurely.

What You Should Do

Check your medication packaging for Daytrana (methylphenidate transdermal system) 10 mg patches with NDC 68968-5552-3.
Identify if your product is affected by looking for Lot Number 82237 with an expiration date of May 31, 2018.
Contact your healthcare provider or pharmacist immediately for guidance on using this medication and to obtain a replacement prescription if necessary.
Return any unused patches from the affected lot to the pharmacy where they were purchased for a refund.
Contact Noven Pharmaceuticals, Inc. at 1-877-567-7857 for further instructions regarding the return of the product.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Daytrana (methylphenidate transdermal system) 10 mg (30 Patches)

Model:

NDC 68968-5552-3

Lot Numbers:

82237 (Exp. May 31, 2018)

Date Ranges: May 31, 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79781

Status: Resolved

Manufacturer: Noven Pharmaceuticals, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 9016 boxes of 30 patch each

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

Check your medication packaging for Daytrana (methylphenidate transdermal system) 10 mg patches with NDC 68968-5552-3.

Identify if your product is affected by looking for Lot Number 82237 with an expiration date of May 31, 2018.

Contact your healthcare provider or pharmacist immediately for guidance on using this medication and to obtain a replacement prescription if necessary.

Return any unused patches from the affected lot to the pharmacy where they were purchased for a refund.

Contact Noven Pharmaceuticals, Inc. at 1-877-567-7857 for further instructions regarding the return of the product.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).