Use caution Drug recall · FDA · Published July 5, 2011

Daytrana Patch Recall: Defective Delivery System Hazard

Noven Pharmaceuticals recalls Daytrana patches due to miscalibrated delivery systems that may affect the ability to remove the release liner.

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

🇺🇸 FDA recall #D-1374-2012Drug Noven Pharmaceuticals ›

Use caution until it’s fixed

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Take action

Contact the company

Recalling firmNoven Pharmaceuticals, Inc.11960 Sw 144th St · Miami, FL 33186-6109

✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals is recalling specific lots of Daytrana transdermal system patches because they may have a miscalibrated or defective delivery system. This defect involves issues with the mechanical peel force and the z-statistic value, which relates to how easily a patient can remove the release liner from the patch adhesive before use. The recall affects 244,320 patches distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/48974-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers.

Source Summary by GovInfoNow · govinfonow.com/recall/48974-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers · Updated October 13, 2026 · FDA enforcement record: FDA #D-1374-2012

Cite this page

“Daytrana Patch Recall: Defective Delivery System Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48974-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers. Based on FDA recall #D-1374-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1374-2012%22&limit=1).

The FDA announced on July 5, 2011, that Noven Pharmaceuticals Inc. is recalling Daytrana transdermal patches due to a defective delivery system. The agency issued recall number D-1374-2011 for the voluntary Class II action.

How to tell if you have it

Brand: Noven Pharmaceuticals
Product: Daytrana Transdermal Patch 15 mg
NDC: 54092-553-01 (1 patch per pouch)
NDC: 54092-553-30 (30-count patches per box)
Lot #: 43783
Expiration Date: 01/12
Distribution: Nationwide and Puerto Rico

The hazard

The patches may have miscalibrated or defective delivery systems, resulting in out-of-specification mechanical peel force or z-statistic values. This defect relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc. has 24 other recalls on record since March 22, 2012. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024), Noven Daytrana 30mg Transdermal System Recall (March 10, 2023), and Noven Daytrana patches recalled due to defective adhesive delivery (Nov. 16, 2022). Other recent recalls of similar products include Nivagen Zinc Oxide Ointment Recall (Oct. 31, 2025), Blossom Pharmaceuticals Dynashield Skin Protectant Recall (Oct. 31, 2025), and Dabur Med Pride Bacitracin Zinc Ointment Recall (June 2, 2026).

How to tell if you have this one

Check if you have Daytrana patches manufactured by Noven Pharmaceuticals Inc., Miami, FL. Specifically look for Lot #43783 with an expiration date of 01/12. The product is identified by NDC 54092-553-01 (single patch) and NDC 54092-553-30 (30-count box).

Brand
Noven Pharmaceuticals
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 and Puerto Rico.

Recall number	Product, codes & lots	Quantity	NDC
D-1372-2012	Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.; Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13	357,510 patches	68968-5552-3, 68968-5553-3, 68968-5554-3, 68968-5555-3, 54092-554-30
D-1373-2012	Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.; Lot #: 43008, Exp 01/12; 48591, Exp 10/12	242,100 patches	—
D-1374-2012	Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.; Lot #: 43783, Exp 01/12	244,320 patches	—
D-1375-2012	Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.; Lot #: 41843, Exp 11/11	335,190 patches	—

Based on the official FDA remedy

What to do — step by step

Check Your Lot Number
Verify if your Daytrana patches match Lot #43783 and expiration date 01/12.
Contact Healthcare Provider
Consult your doctor or pharmacist regarding the recall and alternative treatment options.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Jul 5, 2011Firm started the recall
Jun 14, 2012FDA classified it Class II
Jun 20, 2012Published in FDA’s Enforcement Report
May 23, 2013FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/48974-noven-pharmaceuticals-inc-recalls-daytrana-methylphenidate-transdermal-system-patch-delivers">Daytrana Patch Recall: Defective Delivery System Hazard (GovInfoNow)</a>

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-1374-2012 (July 5, 2011) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1374-2012 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.