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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Daytrana (methylphenidate) Patches Recalled for Adhesive Defect

Agency Publication Date: November 28, 2022
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Summary

Noven Pharmaceuticals Inc. is recalling 3,977 boxes of Daytrana (methylphenidate transdermal system) 15 mg patches because they do not meet quality standards for adhesive properties. The recalled patches, which are used to treat ADHD, were found to be out of specification for "shear," a technical measure of how well the patch sticks. If you have any health concerns or questions about your medication, you should contact your doctor or pharmacist.

Risk

The patch adhesive may fail, which can cause the patch to detach from the skin or lead to inconsistent delivery of the medication. This could result in the patient receiving an incorrect dose of methylphenidate.

What You Should Do

  1. This recall affects Daytrana (methylphenidate transdermal system) patches that deliver 15 mg over 9 hours (1.6 mg/hr), sold in boxes of 30 patches (NDC 68968-5553-3).
  2. Check your medication packaging for lot number 91316 with an expiration date of 02/2023.
  3. 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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Daytrana (methylphenidate transdermal system)
Variants: 15 mg over 9 hours, 1.6 mg/hr, 30 patches per box, Rx only
Lot Numbers:
91316 (Exp. 02/2023)
NDC:
68968-5553-3

Recall #: D-0071-2023; Manufactured for Noven Therapeutics, LLC and By Noven Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91161
Status: Active
Manufacturer: Noven Pharmaceuticals Inc
Sold By: Retail Pharmacies
Manufactured In: United States
Units Affected: 3977 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 ยท 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.