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Lower risk Drug recall · FDA · Published March 10, 2023

Noven Daytrana 30mg Transdermal System Recall: Defective Delivery System Risk

Noven Pharmaceuticals recalls Daytrana (methylphenidate transdermal system) 30mg 30-count cartons with defective delivery system. Affected lots expire 3/2023 to 10/2023. Stop using immediately if you have these products.

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

🇺🇸 FDA recall #D-0473-2023DrugNoven ›
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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 system) 30mg 30-count cartons due to a defective delivery system that may not function properly. This could lead to inconsistent medication delivery, potentially causing treatment failure or adverse effects. Read more at govinfonow.com/recall/33822-noven-daytrana-30mg-transdermal-system-recall-defective-delivery-system-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33822-noven-daytrana-30mg-transdermal-system-recall-defective-delivery-system-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0473-2023

Cite this page

“Noven Daytrana 30mg Transdermal System Recall: Defective Delivery System Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33822-noven-daytrana-30mg-transdermal-system-recall-defective-delivery-system-risk. Based on FDA recall #D-0473-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0473-2023%22&limit=1).

The FDA announced on March 10, 2023, that Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate transdermal system) CII due to a defective delivery system out of specification for shear. The agency issued recall number D-0473-2023 for the voluntary Class II action.

How to tell if you have it

  • Brand: Noven
  • Product: Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only
  • NDC: 68968-5555-3
  • Lot codes: 91474, 91959, 91958, 92478, 92479, 92198, 92199, 93040, 93041
  • Expiration dates: 3/2023, 6/2023, 7/2023, 8/2023, 9/2023, 10/2023
  • Sold: US Nationwide

The hazard

The recall involves a defective delivery system where the product is out of specification for shear. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since July 5, 2011. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024), Noven Daytrana patches recalled due to defective adhesive delivery (Nov. 16, 2022), and Noven Daytrana patches recalled due to ripping and adhesive issues (June 24, 2022). Other recent recalls of similar products include Bionpharma Divalproex Tablets Recall (June 26, 2026), Supernus Trokendi XR 50mg Capsules: Failed Dissolution Specifications Recall (Aug. 31, 2026), and Supernus Trokendi XR 25mg Capsules: Failed Dissolution Risk (July 6, 2026).

How to tell if you have this one

Check your Daytrana 30mg 30-count carton for the lot numbers listed: 91474, 91959 (expiring 3/2023), 91958 (expiring 6/2023), 92478 (expiring 7/2023), 92479 & 92198 (expiring 8/2023), 92199 and 93040 (expiring 9/2023), 93041 (expiring 10/2023).

  • 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
    Ongoing
  • Distribution
    US Nationwide
  • NDC
    68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3
Recall numberProduct, codes & lots
D-0470-2023Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.; Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023
D-0471-2023Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3; Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023
D-0472-2023Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.; Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
D-0473-2023Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3; Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for the lot numbers listed in the recall: 91474, 91959, 91958, 92478, 92479, 92198, 92199, 93040, 93041.

  2. Stop Using Immediately

    If you have the recalled lot numbers, stop using the Daytrana product immediately.

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 published this recall 19 days after the firm started it.

1. Firm started the recall: Mar 10, 202312. FDA classified it Class II: Mar 20, 202323. Published in FDA’s Enforcement Report: Mar 29, 202332023
  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.

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Keep exploring

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-0473-2023 (March 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0473-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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