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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

Noven Pharmaceuticals, Inc.: Daytrana (methylphenidate) Patches Recalled for Defective Delivery System

Agency Publication Date: September 18, 2017
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Summary

Noven Pharmaceuticals, Inc. is recalling approximately 1,071,660 patches of Daytrana (methylphenidate transdermal system), a prescription medication used to treat ADHD. The recall was initiated because the products no longer meet the specific standards for how the protective liner is removed from the patch and other physical delivery specifications. This defect could make the patches difficult to use or affect how the medication is delivered. Consumers should contact their healthcare provider or pharmacist regarding this recall of 10 mg, 15 mg, 20 mg, and 30 mg strength patches.

Risk

The defective delivery system means the release liner may not peel away correctly from the medication patch as intended. This can lead to improper application or potential issues with the patch adhering to the skin, which may impact the consistent delivery of the medication.

What You Should Do

  1. Check your medication packaging for the product name Daytrana (methylphenidate transdermal system) and look for the specific lot numbers and expiration dates listed below.
  2. If you have 10 mg patches (NDC 68968-5552-3), check for lot 80433 with expiration date 08/17.
  3. If you have 15 mg patches (NDC 68968-5553-3), check for lot 80426 with expiration date 10/17.
  4. If you have 20 mg patches (NDC 68968-5554-3), check for lot 80431 with expiration date 08/17.
  5. If you have 30 mg patches (NDC 68968-5555-3), check for lots 80442 (Exp. 10/17), 80439 (Exp. 08/17), or 80438 (Exp. 08/17).
  6. Contact your healthcare provider or pharmacist for guidance on continuing your treatment and to report any issues with patch application.
  7. Return any unused, affected patches to your pharmacy for a refund and contact Noven Pharmaceuticals at their Miami facility if you have further questions.
  8. For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical product return and guidance.

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
Recall #: D-1169-2017
Lot Numbers:
80433 (Exp. 08/17)
Date Ranges: 08/17
Product: Daytrana (methylphenidate transdermal system) 20 mg (30 Patches)
Model:
NDC# 68968-5554-3
Recall #: D-1170-2017
Lot Numbers:
80431 (Exp. 08/17)
Date Ranges: 08/17
Product: Daytrana (methylphenidate transdermal system) 30 mg (30 Patches)
Model:
NDC# 68968-5555-3
Recall #: D-1171-2017
Lot Numbers:
80442 (Exp. 10/17)
80439 (Exp. 08/17)
80438 (Exp. 08/17)
Date Ranges: 08/17, 10/17
Product: Daytrana (methylphenidate transdermal system) 15 mg (30 Patches)
Model:
NDC# 68968-5553-3
Recall #: D-1172-2017
Lot Numbers:
80426 (Exp. 10/17)
Date Ranges: 10/17

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78021
Status: Resolved
Manufacturer: Noven Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4 products (321,900 patches; 182,850 patches; 331,950 patches; 234,960 patches)
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.