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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 Therapeutics, LLC: Daytrana (methylphenidate) Patches Recalled for Defective Delivery System

Agency Publication Date: March 19, 2020
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Summary

Noven Therapeutics is recalling approximately 41,836 boxes of Daytrana (methylphenidate transdermal system) patches across four different dosage strengths. The patches, which are used to treat ADHD, are being recalled because they failed mechanical testing for peel and shear strength, meaning the delivery system may not work as intended. Consumers who use these patches should contact their healthcare provider or pharmacist for guidance regarding their treatment.

Risk

The delivery system is out of specification for mechanical peel and shear, which could affect how the patch adheres to the skin or how the medication is released, potentially resulting in incorrect dosing or ineffective treatment.

What You Should Do

  1. Check your medication packaging to see if you have Daytrana (methylphenidate) patches with the following NDC numbers: 68968-5552-3 (10 mg), 68968-5553-3 (15 mg), 68968-5554-3 (20 mg), or 68968-5555-3 (30 mg).
  2. Verify the specific lot numbers and expiration dates on the side of the 30-count box or individual patch pouches. Affected lots include 86280 (Exp 06/2020), 85942 (Exp 03/2020), 86281 (Exp 06/2020), 86081 (Exp 04/2020), 86196 (Exp 06/2020), 86083 (Exp 05/2020), and 86282 (Exp 06/2020).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using a patch from an affected lot.
  4. Return any unused boxes or patches from these specific lots to your pharmacy for a refund.
  5. Contact Noven Therapeutics, LLC at their Miami, Florida facility or through your pharmacist for further instructions regarding this recall.
  6. For additional questions, call 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

Healthcare provider consultation and pharmacy return.

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) patches, 10 mg over 9 hours (30-count box)
Model:
NDC 68968-5552-3
Recall #: D-1042-2020
Lot Numbers:
86280 (Exp 06/2020)
Date Ranges: Expiration: June 2020
Product: Daytrana (methylphenidate transdermal system) patches, 15 mg over 9 hours (30-count box)
Model:
NDC 68968-5553-3
Recall #: D-1043-2020
Lot Numbers:
85942 (Exp 03/2020)
86281 (Exp 06/2020)
Date Ranges: Expiration: March 2020, Expiration: June 2020
Product: Daytrana (methylphenidate transdermal system) patches, 20 mg over 9 hours (30-count box)
Model:
NDC 68968-5554-3
Recall #: D-1044-2020
Lot Numbers:
86081 (Exp 04/2020)
86196 (Exp 06/2020)
Date Ranges: Expiration: April 2020, Expiration: June 2020
Product: Daytrana (methylphenidate transdermal system) patches, 30 mg over 9 hours (30-count box)
Model:
NDC 68968-5555-3
Recall #: D-1045-2020
Lot Numbers:
86083 (Exp 05/2020)
86282 (Exp 06/2020)
Date Ranges: Expiration: May 2020, Expiration: June 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85128
Status: Resolved
Manufacturer: Noven Therapeutics, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4 products (9513 boxes; 13761 boxes; 11093 boxes; 7469 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.