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Use caution Drug recall · FDA · Published July 27, 2015

Daytrana 30mg Patch Recall: Defective Delivery System

Noven Pharmaceuticals recalls Daytrana 30 mg over 9 Hour Patches due to a defective delivery system affecting mechanical peel force.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0008-2016DrugDaytrana ›
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Contact the company

Recalling firmNoven Pharmaceuticals, Inc.11960 SW 144th St · Miami, FL 33186-6109
✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals, Inc. is recalling Daytrana (methylphenidate transdermal system), specifically the 30 mg over 9 Hour Patches (3.3 mg/hr) in 30 Ct Cartons. The recall affects product manufactured for Noven Therapies, LLC with NDC 68968-5555-3 and Lot #75983, which expires on 11/15. Approximately 125,250 patches are involved in this nationwide distribution. Read more at govinfonow.com/recall/43898-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-30-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/43898-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-30-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0008-2016

Cite this page

“Daytrana 30mg Patch Recall: Defective Delivery System.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43898-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-30-mg. Based on FDA recall #D-0008-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2016%22&limit=1).

The Food and Drug Administration announced on 2015-07-27 that Noven Pharmaceuticals Inc. voluntarily recalled Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches, due to a defective delivery system. The agency stated the recall affects approximately 125,250 patches distributed nationwide.

How to tell if you have it

  • Brand: Daytrana
  • Product: Daytrana 30 mg Patches
  • NDC: 68968-5555-3
  • Lot #: 75983
  • Expiry: 11/15

The hazard

According to the FDA, the product is out of specification for z-statistic related to mechanical peel force. The recall is classified as a Class II recall.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since 2011-07-05. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (2024-10-31), Noven Daytrana 20mg Transdermal System Recall (2023-03-10), and Noven Daytrana patches recalled due to defective adhesive delivery (2022-11-16). Other recent recalls of similar products include Xyvona (Levorphanol) 2mg Tablet Recall (2026-05-22) and Wells Pharma Fentanyl Citrate Injectable Solution Recall (2026-04-01).

How to tell if you have this one

Check your Daytrana box for NDC 68968-5555-3 and Lot #75983. Verify that the expiry date is 11/15. The product is a 30 mg over 9 Hour Patch (3.3 mg/hr) in a 30 Ct Carton, Rx Only.

  • Brand
    Daytrana
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Lot Number

    Verify if your Daytrana patch box contains Lot #75983 and NDC 68968-5555-3 with an expiry date of 11/15.

  2. Contact Your Pharmacist

    If you have the recalled lot, speak with your pharmacist or healthcare provider to determine the next steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US 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 3.6 years after the firm started it.

1. Firm started the recall: Jul 27, 201512. FDA classified it Class II: Oct 6, 201523. Published in FDA’s Enforcement Report: Oct 14, 201534. FDA terminated the recall: Mar 20, 2019420152019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-0008-2016 (July 27, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0008-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 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