Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals recalls specific lots of Daytrana patches because the release liner may be difficult to remove, affecting proper administration.
Use caution until it’s fixed
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Contact the company
What happened, in plain English
Noven Pharmaceuticals is recalling a specific lot of Daytrana (methylphenidate transdermal system) patches that deliver 20 mg over 9 hours. The recall is due to a defective delivery system where the mechanical peel force and z-statistic values are out of specification. This defect may make it difficult for patients or caregivers to remove the release liner from the patch adhesive before use. Read more at govinfonow.com/recall/45940-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers.
Source Summary by GovInfoNow · govinfonow.com/recall/45940-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers · Updated October 12, 2026 · FDA enforcement record: FDA #D-1608-2014
Cite this page
“Noven Recalls Daytrana Patches Due to Defective Delivery System.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45940-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers. Based on FDA recall #D-1608-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1608-2014%22&limit=1).
Why it’s dangerous
The patch's release liner is designed to be peeled off before application, but the mechanical peel force and z-statistic values are out of specification. This means the liner might not separate easily from the adhesive, potentially preventing proper administration of the medication.
Who’s affected
Patients prescribed Daytrana patches who possess lot number 71165 with an expiration date of 12/14 are affected. Caregivers assisting these patients may also be impacted by the difficulty in removing the liner.
How to tell if you have this one
Check your Daytrana patches for NDC 68968-5554-3. Verify that the lot number is 71165 and the expiration date is 12/14. The product was manufactured by Noven Pharmaceuticals, Inc. in Miami, FL.
- Brand
Noven Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Patch Details
Verify that your Daytrana patch has NDC 68968-5554-3, lot number 71165, and an expiration date of 12/14.
Contact Your Healthcare Provider
Speak with your doctor or pharmacist to determine the appropriate next steps for your treatment plan.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.7 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.
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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-1608-2014 (July 15, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1608-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.