Daytrana Patch Recall: Defective Peel Force Hazard
Noven Pharmaceuticals recalls Daytrana 20mg patches due to defective delivery system. Learn who is affected and what the hazard entails.
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, Inc. has recalled a specific lot of Daytrana (methylphenidate transdermal system) Transdermal Patches, 20 mg over 9 hours. The recall addresses a defective delivery system where the mechanical peel force and z-statistic values are out of specification. This defect may impair patients and caregivers from removing the release liner from the patch adhesive before use. Read more at govinfonow.com/recall/43318-daytrana-patch-recall-defective-peel-force-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/43318-daytrana-patch-recall-defective-peel-force-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-1439-2016
Cite this page
“Daytrana Patch Recall: Defective Peel Force Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43318-daytrana-patch-recall-defective-peel-force-hazard. Based on FDA recall #D-1439-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1439-2016%22&limit=1).
Why it’s dangerous
The patch's release liner may be difficult or impossible to peel off due to out-of-specification mechanical peel force values. This prevents proper administration of the medication because the adhesive cannot be exposed as intended.
Who’s affected
Patients prescribed Daytrana patches who possess Lot # 77140 with an expiration date of 05/16 are affected. Caregivers responsible for applying these patches to patients are also at risk of being unable to remove the liner properly.
How to tell if you have this one
Check your box for NDC 68968-5554-3 and Lot # 77140 with an expiration date of 05/16. The product is a 20 mg over 9 hours (2.2 mg/hr) transdermal patch packaged in 30-count boxes, manufactured by Noven Therapeutics, LLC in Miami, FL.
- Brand
Daytrana- 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- NDC
68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1438-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 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 68968-5553-3.; Lot #: 77303, Exp 06/16 | 7850 boxes |
| D-1439-2016 | 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 # 77140, Exp 05/16 | 2088 boxes |
| D-1440-2016 | 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 #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16 | 12285 boxes |
What to do — step by step
Check Your Lot Number
Verify if your Daytrana patch box contains Lot # 77140 and expires on 05/16.
Contact Noven Pharmaceuticals
Reach out to the manufacturer for further instructions regarding this defective delivery system issue.
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 3.2 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-1439-2016 (December 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1439-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.