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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: April 17, 2020
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Summary

Noven Therapeutics, LLC is recalling 27,713 boxes of Daytrana (methylphenidate transdermal system), a prescription skin patch used to treat ADHD. The recall affects three different dosage strengths (10 mg, 20 mg, and 30 mg) because the patches failed mechanical testing for peel and shear. This defect means the patches may be difficult to use or may not adhere and deliver medication correctly. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments or to determine if their specific box is affected.

Risk

The delivery system is defective because it is 'out of specification' for how the patch peels and adheres to the skin. This could lead to a failure in delivering the intended dose of medication or difficulty in applying the patch properly.

What You Should Do

  1. Check your Daytrana (methylphenidate transdermal system) packaging for the following specific strengths and lot details: 10 mg (Lot 86647, Exp. 09/2020), 20 mg (Lot 86354, Exp. 08/2020), or 30 mg (Lots 86355 Exp. 07/2020, 86356 Exp. 08/2020, 86550 Exp. 07/2020, 87348 Exp. 01/2021, and 87965 Exp. 01/2021).
  2. Look for National Drug Codes (NDC) on the box: NDC 68968-5552-3 for 10 mg, NDC 68968-5554-3 for 20 mg, or NDC 68968-5555-3 for 30 mg.
  3. If you have an affected lot, contact your healthcare provider or pharmacist immediately for guidance on your medication schedule and to obtain a replacement prescription if necessary.
  4. Return any unused portions of the affected medication to your pharmacy for a refund and further instructions.
  5. Contact Noven Therapeutics at their Miami, Florida facility or through your pharmacist if you have specific questions regarding this voluntary recall.
  6. For additional information, you may 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

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) 10 mg over 9 hours (30-count box)
Model:
NDC 68968-5552-3
Recall #: D-1247-2020
Lot Numbers:
86647 (Exp. 09/2020)
Date Ranges: September 2020
Product: Daytrana (methylphenidate transdermal system) 20 mg over 9 hours (30-count box)
Model:
NDC 68968-5554-3
Recall #: D-1248-2020
Lot Numbers:
86354 (Exp. 08/2020)
Date Ranges: August 2020
Product: Daytrana (methylphenidate transdermal system) 30 mg over 9 hours (30-count box)
Model:
NDC 68968-5555-3
Recall #: D-1249-2020
Lot Numbers:
86355 (Exp. 07/2020)
86356 (Exp. 08/2020)
86550 (Exp. 07/2020)
87348 (Exp. 01/2021)
87965 (Exp. 01/2021)
Date Ranges: July 2020, August 2020, January 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85357
Status: Resolved
Manufacturer: Noven Therapeutics, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3 products (7957 30-count boxes; 5,614 30-count boxes; 14,142 30-count 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.