Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only,
Noven Therapeutics recalls Daytrana (methylphenidate transdermal system) 30-count boxes due to defective delivery system causing inconsistent dosing. No remedy specified in official notice.
Recall notice
Defective Delivery System: Out of specification for mechanical peel and shear.
Contact the company & request your remedy
What happened, in plain English
Noven Therapeutics is recalling Daytrana (methylphenidate transdermal system) 30-count boxes because the delivery system may not work properly. This could lead to inconsistent medication dosing, which is important for people using ADHD medication. Read more at govinfonow.com/recall/37204-daytrana-30-count-box-recall-defective-delivery-system-risks-inconsistent.
Source Summary by GovInfoNow · govinfonow.com/recall/37204-daytrana-30-count-box-recall-defective-delivery-system-risks-inconsistent · Updated October 5, 2026 · FDA enforcement record: FDA #D-1247-2020
Cite this page
“Daytrana 30-count box recall: Defective delivery system risks inconsistent dosing.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37204-daytrana-30-count-box-recall-defective-delivery-system-risks-inconsistent. Based on FDA recall #D-1247-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1247-2020%22&limit=1).
Why it’s dangerous
The delivery system may not function correctly, leading to inconsistent medication release. This could cause either too little or too much medication to be delivered over time, affecting treatment effectiveness.
Who’s affected
People with prescriptions for Daytrana (methylphenidate transdermal system) 30-count boxes. Those using the medication for ADHD are most at risk due to potential dosing inconsistencies.
How to tell if you have this one
Check for Daytrana 30-count boxes with NDC 68968-5552-3, manufactured by Noven Therapeutics in Miami, FL, with lot number 86647 expiring 09/2020.
- Brand
Noven Therapeutics- 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
Distributed Nationwide in the US- NDC
68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1247-2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3; Lot: 86647 Exp. 09/2020 | 7957 30-count boxes |
| D-1248-2020 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3; Lot: 86354 Exp. 08/2020 | 5,614 30-count boxes |
| D-1249-2020 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3; Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021 | 14,142 30-count boxes |
What to do — step by step
Check Product Details
Verify the product label for NDC 68968-5552-3, Miami, FL manufacturing, and lot 86647 expiration 09/2020.
Questions people ask
Is there a remedy for this recall?
The official notice does not specify a remedy.
What is the specific problem with Daytrana in this recall?
The delivery system may not function correctly, causing inconsistent medication release.
How can I tell if I have the recalled product?
Look for Daytrana 30-count boxes with NDC 68968-5552-3, manufactured by Noven Therapeutics in Miami, FL, lot 86647 expiring 09/2020.
Contact Noven Therapeutics
We’ve drafted a message you can send Noven Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-1247-2020 — Noven Therapeutics Noven Therapeutics Hello, I own a Noven Therapeutics that is covered by recall D-1247-2020 from Noven Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1247-2020 (March 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1247-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.