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Lower risk Drug recall · FDA · Published November 16, 2022

Noven Daytrana patches recalled due to defective adhesive delivery

Noven Pharmaceuticals recalls Daytrana patches (15mg over 9 hours) with defective adhesive that may not deliver medication properly. Affected lots were manufactured in Miami, FL, with expiration 02/2023.

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

🇺🇸 FDA recall #D-0071-2023DrugNoven ›
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Contact the company

Recalling firmNoven Pharmaceuticals Inc11960 Sw 144th St · Miami, FL 33186-6109
✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal patches) because the adhesive quality was defective. This could lead to inconsistent medication delivery, which might affect treatment effectiveness for ADHD. Read more at govinfonow.com/recall/34221-noven-daytrana-patches-recalled-due-to-defective-adhesive-delivery.

Source Summary by GovInfoNow · govinfonow.com/recall/34221-noven-daytrana-patches-recalled-due-to-defective-adhesive-delivery · Updated August 17, 2026 · FDA enforcement record: FDA #D-0071-2023

Cite this page

“Noven Daytrana patches recalled due to defective adhesive delivery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/34221-noven-daytrana-patches-recalled-due-to-defective-adhesive-delivery. Based on FDA recall #D-0071-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0071-2023%22&limit=1).

The FDA announced on 2022-11-16 that Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate transdermal system) due to a defective delivery system. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Noven
  • Product: Daytrana (methylphenidate transdermal system)
  • Dosage: Delivers 15 mg over 9 hours, (1.6 mg/hr)
  • Packaging: 30 patches per box, Rx only
  • NDC: 68968-5553-3
  • Lot: 91316
  • Expiration: Exp. 02/2023

The hazard

According to the FDA, the recalled lot was found to be out of specification for shear, an attribute related to the adhesive properties of the transdermal patches.

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 10mg Transdermal System Recall (2023-03-10), and Noven Daytrana patches recalled due to ripping and adhesive issues (2022-06-24).

How to tell if you have this one

Check for Daytrana patches labeled with lot number 91316 and expiration date 02/2023. The product is a prescription-only transdermal system delivering 15mg over 9 hours.

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

What to do — step by step

  1. Check Product Details

    Look for the lot number 91316 and expiration date 02/2023 on the patch packaging.

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: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

1. Firm started the recall: Nov 16, 202212. FDA classified it Class II: Nov 28, 202223. Published in FDA’s Enforcement Report: Dec 7, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall is for defective adhesive quality, not safety risks. The product is safe to use if it's not the recalled lot.

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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-0071-2023 (November 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0071-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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