The Recall Desk
ModerateFDA (Drugs)·D-1373-2012·Announced 2012-06-20

Daytrana Transdermal Patch Recalled for Defective Delivery System

Noven Pharmaceuticals is recalling Daytrana transdermal patches because the release liner may be difficult to remove. This could affect the patient's ability to apply the medication correctly.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a mechanical defect affecting the ease of removing the liner rather than a direct toxicological or structural failure causing immediate injury. This aligns with the 'Moderate' criteria for minor labeling or functional errors without reported serious harm.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling Daytrana (methylphenidate) transdermal system patches. The recall involves 242,100 patches distributed nationwide and in Puerto Rico. The affected lots are 43008 (Exp 01/12) and 48591 (Exp 10/12).

The recall was initiated because the patches have out-of-specification results for mechanical peel force and the z-statistic value. These defects relate to the patient's ability to remove the release liner from the patch adhesive prior to administration. This issue may make it difficult for patients to properly prepare the patch for use.

Consumers with these specific lots should stop using the product and contact their healthcare provider or the recalling firm for instructions on how to proceed.

The recalled product

Product
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., Mi
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
242,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 43008
  • Exp 01/12
  • 48591
  • Exp 10/12

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Noven Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · defective delivery system

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