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Drug recall · FDA · Published February 19, 2021

Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a

Noven Pharmaceuticals recalls Daytrana patches due to defective delivery system. Out of specification mechanical peel may cause inconsistent medication release. Affected lots from 87377 to 88939 expiring 3/2021 to 8/2021.

🇺🇸 FDA recall #D-0296-2021DrugNoven ›
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Contact the company & request your remedy

Recalling firmNoven Pharmaceuticals Inc11960 Sw 144th St · Miami, FL 33186-6109
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal patches) because the delivery system may not work properly. This could lead to inconsistent medication release, which might affect treatment effectiveness. Read more at govinfonow.com/recall/36503-noven-daytrana-patches-recall-defective-delivery-system-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36503-noven-daytrana-patches-recall-defective-delivery-system-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0296-2021

Cite this page

“Noven Daytrana Patches Recall: Defective Delivery System Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36503-noven-daytrana-patches-recall-defective-delivery-system-risk. Based on FDA recall #D-0296-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2021%22&limit=1).

Why it’s dangerous

The patches have a mechanical peel issue that may not release medication as intended. This could cause inconsistent dosing, but the recall does not mention immediate injury risks.

Who’s affected

People prescribed Daytrana for ADHD who have the recalled patches. Those with specific lot numbers from 87377 to 88939 expiring through August 2021 are most at risk.

How to tell if you have this one

Check the lot number on the packaging, which ranges from 87377 to 88939. The expiration dates are between March 2021 and August 2021. Daytrana is a prescription medication for ADHD.

  • Brand
    Noven
  • Category
    Drug
FDA recall event · 4 products

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 in the USA
  • NDC
    68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3
Recall numberProduct, codes & lotsQuantity
D-0293-2021Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.; Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021.473,280 patches
D-0294-2021Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.; Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.551,670 patches
D-0295-2021Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.; Lots #: 87580, Exp 4/2021, 87819, Exp 4/2021, 88244, Exp 6/2021, 88245, Exp 6/2021, 88532, Exp 06/2021 & 88533, Exp 7/2021.786,900 patches
D-0296-2021Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.; Lots #: 87377, Exp 3/2021, 87572, Exp 3/2021, 87581, Exp 4/2021, 87820, Exp 5/2021, 88246, Exp 6/2021, 88535, Exp 7/2021, 88536, Exp 8/2021, 88537, Exp 8/2021 & 88939, Exp 8/2021.934,140 patches
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for the lot number on the packaging, which is between 87377 and 88939.

  2. Contact Your Doctor

    Talk to your healthcare provider about whether you need a replacement or alternative treatment.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the delivery system may not work properly, but it does not indicate immediate safety risks. Consult your doctor for personalized advice.

What should I do if I have the recalled product?

Check the lot number on the packaging. If it matches the recalled range, contact your doctor to discuss alternatives or a replacement.

How can I tell if I have the recalled product?

The product has a lot number between 87377 and 88939 with expiration dates from March 2021 to August 2021.

Take action

Contact Noven

We’ve drafted a message you can send Noven to request your refund or repair — edit it as you like.

Subject: Recall D-0296-2021 — Noven Noven

Hello,

I own a Noven that is covered by recall D-0296-2021 from Noven.

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-0296-2021 (February 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0296-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA