The Recall Desk
ModerateFDA (Drugs)·D-1654-2012·Announced 2012-08-29

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 121,530 Daytrana patches because the release liner may be difficult to remove. The defect affects the patch's mechanical peel force.

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, and the hazard involves a mechanical defect in the delivery system (difficulty removing the liner) rather than a high-risk pathogen or structural failure causing injury.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 121,530 units of Daytrana (methylphenidate) transdermal system patches. The recall involves Lot # 56506 with an expiration date of 12/12. The product is a prescription-only medication that delivers 30 mg of methylphenidate over 9 hours.

The recall was initiated because the patches have out-of-specification results for mechanical peel force and/or the z-statistic value. These defects relate to the patient's ability to remove the release liner from the patch adhesive prior to administration. The affected patches were distributed nationwide and in Puerto Rico.

Consumers should stop using the recalled patches and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
121,530

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 (2)

  • Lot # 56506
  • Exp 12/12

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 3 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 3 products in this recall →

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · defective delivery system

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