Daytrana Patch Recall: Defective Delivery System
Noven Pharmaceuticals recalls Daytrana patches due to defective delivery systems that may not meet release liner or z-statistic specifications.
Use caution until it’s fixed
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
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What happened, in plain English
Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate transdermal system) patches because the products no longer meet the release liner removal specification and/or z-statistic. This defect affects the delivery system, potentially impacting how the medication is released. The recall covers approximately 331,950 patches distributed nationwide. Read more at govinfonow.com/recall/41289-daytrana-patch-recall-defective-delivery-system.
Source Summary by GovInfoNow · govinfonow.com/recall/41289-daytrana-patch-recall-defective-delivery-system · Updated October 11, 2026 · FDA enforcement record: FDA #D-1171-2017
Cite this page
“Daytrana Patch Recall: Defective Delivery System.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41289-daytrana-patch-recall-defective-delivery-system. Based on FDA recall #D-1171-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1171-2017%22&limit=1).
Why it’s dangerous
The hazard is a defective delivery system where products fail to meet release liner removal specifications or z-statistic requirements. This defect means the patch may not deliver the methylphenidate correctly, potentially leading to under-dosing or inconsistent medication release.
Who’s affected
Patients who have been prescribed Daytrana transdermal patches and possess the specific lots listed in the record are affected. Individuals using these patches may receive medication that does not perform as intended due to the defective delivery system.
How to tell if you have this one
Check your Daytrana patches for NDC# 68968-5555-3 and one of the following lot numbers with their expiration dates: Lot 80442 (Exp. 10/17), Lot 80439 (Exp. 08/17), or Lot 80438 (Exp. 08/17). These patches were manufactured for Noven Therapeutics, LLC in Miami, FL.
- Brand
Daytrana- Category
Drug
All 4 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-1169-2017 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3; Lot: 80433 Exp. 08/17 | 321,900 patches |
| D-1170-2017 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3; Lot: 80431 Exp. 08/17 | 182,850 patches |
| D-1171-2017 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3; Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17 | 331,950 patches |
| D-1172-2017 | Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3; Lot: 80426 Exp. 10/17 | 234,960 patches |
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 2.4 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-1171-2017 (August 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1171-2017 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.