Noven Daytrana patches recalled due to delivery system defect
Noven Pharmaceuticals recalls Daytrana transdermal patches with defective delivery system that may not release medication properly. Affected patches have specific lot numbers and expiration dates.
Lower-risk recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Contact the company
What happened, in plain English
Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal patches) because the delivery system may not function correctly. This could lead to inconsistent medication release, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/42479-noven-daytrana-patches-recalled-due-to-delivery-system-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/42479-noven-daytrana-patches-recalled-due-to-delivery-system-defect · Updated October 9, 2026 · FDA enforcement record: FDA #D-0429-2017
Cite this page
“Noven Daytrana patches recalled due to delivery system defect.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42479-noven-daytrana-patches-recalled-due-to-delivery-system-defect. Based on FDA recall #D-0429-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0429-2017%22&limit=1).
Why it’s dangerous
The patches have manufacturing defects in the mechanical peel force and z-statistic values, which may cause the medication to not be delivered properly over time. This could result in inconsistent medication levels in the body.
Who’s affected
People prescribed Daytrana patches by a doctor who own the recalled lot numbers (79230 or 77547) are affected. Children and adults using the medication are at risk if the patches don't release medication as intended.
How to tell if you have this one
Check the lot number on the box: 79230 (expires 02/2017) or 77547 (expires 07/2016). The product is a 20 mg transdermal patch system for ADHD treatment, sold by prescription.
- Brand
Noven- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the US- NDC
68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0428-2017 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3; Lot #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017. | 1,068,600 patches |
| D-0429-2017 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.; Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016 | 364,830 patches |
| D-0430-2017 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.; Lot #: 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016. | 357,420 patches |
What to do — step by step
Check Patch Lot Number
Look for lot numbers 79230 or 77547 on the box.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 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
Is this patch safe to use?
The recall indicates a potential issue with consistent medication delivery, but no immediate safety risk is stated.
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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-0429-2017 (August 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0429-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.