Daytrana Patch Recall: Defective Delivery System Hazard
Noven Pharmaceuticals recalls Daytrana patches due to a defective delivery system that may make removing the release liner difficult. Check your lot number.
Use caution until it’s fixed
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
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What happened, in plain English
Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal system patches because they have a defective delivery system. The issue involves out-of-specification results for the z-statistic value, which affects the ability of patients and caregivers to remove the release liner from the patch adhesive before use. This recall covers 335,910 patches distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/48356-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers.
Source Summary by GovInfoNow · govinfonow.com/recall/48356-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers · Updated October 13, 2026 · FDA enforcement record: FDA #D-312-2013
Cite this page
“Daytrana Patch Recall: Defective Delivery System Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48356-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers. Based on FDA recall #D-312-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-312-2013%22&limit=1).
Why it’s dangerous
The defect relates to the z-statistic value concerning the release liner removal. This mechanical issue can make it difficult or impossible for patients and caregivers to separate the liner from the adhesive, potentially preventing the correct application of the medication.
Who’s affected
Patients prescribed Daytrana for ADHD and their caregivers who may have purchased or been dispensed the affected lots are at risk of difficulty using the medication properly. The hazard specifically impacts the ability to prepare the patch for administration.
How to tell if you have this one
Check your Daytrana patch box for NDC 68968-5552-3 and Lot #59824 with an expiration date of 04/13. The product is a 10 mg patch delivering 1.1 mg/hr over 9 hours, packaged as 1 patch per pouch in a 30-count box.
- Brand
Daytrana- Category
Drug
What to do — step by step
Check your lot number
Verify if your Daytrana patches match Lot #59824 and NDC 68968-5552-3 with an expiration date of 04/13.
Contact your pharmacist or doctor
If you have the recalled product, speak with your healthcare provider about obtaining a replacement or alternative treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Who manufactured the recalled patches?
The patches were manufactured for Noven Therapeutics, LLC by Noven Pharmaceuticals, Inc. in Miami, FL.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-312-2013 (January 31, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-312-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.