Noven Pharmaceuticals is recalling a specific lot of Daytrana (Methylphenidate) Transdermal System Patches that deliver 20 mg over 9 hours. The recall was issued because the patches have a miscalibrated or defective delivery system that exceeded specifications for mechanical peel force and/or z-statistic value. This defect could result in the patch delivering more or less medication than intended. Read more at govinfonow.com/recall/48940-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers.
“Noven Recalls Daytrana Patches Due to Delivery System Defect.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48940-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers. Based on FDA recall #D-1413-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1413-2012%22&limit=1).
The FDA announced on March 22, 2012, that Noven Pharmaceuticals Inc. voluntarily recalled Daytrana Transdermal Patches due to a defective delivery system. The agency stated the patches exceeded specifications for mechanical peel force and/or z-statistic values.
How to tell if you have it
Brand: Noven Pharmaceuticals
Product: Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr)
NDC 68968-5554-01 (1 patch per pouch)
NDC 68968-5554-3 (3-count patches per box)
Lot # 53995
Manufactured on 08/04/12
The hazard
The recall addresses miscalibrated or defective delivery systems in the Daytrana patches. The FDA noted that the product exceeded specifications for both mechanical peel force (MPF) and/or the z-statistic value.
Context
GovInfoNow's records show Noven Pharmaceuticals Inc has issued 24 other recalls since July 5, 2011. Recent similar recalls include a Noven Xelstrym patch recall on Oct. 31, 2024, for defective adhesive risk and a Noven Daytrana recall on March 10, 2023, for out-of-specification shear values. Other recent recalls of similar products include an ANI Pharmaceuticals Estradiol Gel recall due to defective containers (May 12, 2026) and a Wells Pharma Fentanyl Citrate Injectable Solution recall for CGMP deviations (April 1, 2026).
How to tell if you have this one
Check if you have Daytrana patches that deliver 20 mg over 9 hours (2.2 mg/hr), with 1 patch per pouch in a 3-count box. Look for NDC 68968-5554-01 on the pouch and NDC 68968-5554-3 on the box. Verify that the lot number is 53995.
Brand
Noven Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check your patch details
Verify that your Daytrana patches match the NDC numbers (68968-5554-01 and 68968-5554-3) and Lot # 53995.
Contact your healthcare provider
Speak with your doctor or pharmacist to discuss the defect and determine if you should continue using this specific lot.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1413-2012 (March 22, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1413-2012 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.