The Recall Desk
ModerateFDA (Drugs)·D-1655-2012·Announced 2012-08-29

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 231,270 Daytrana patches because the release liner may be difficult to remove.

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 safety failure, fitting the criteria for moderate severity.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 231,270 units of Daytrana (methylphenidate) transdermal system patches. The affected product is Lot #53823, with an expiration date of 08/12. The patches are packaged in 30-count boxes and were distributed nationwide and in Puerto Rico.

The recall was initiated because the patches failed to meet specifications for mechanical peel force and z-statistic values. These defects relate to the patient's ability to remove the release liner from the patch adhesive prior to administration. The issue may make it difficult for patients to properly prepare the patch for use.

Consumers who have this specific lot of Daytrana should stop using the product and contact their healthcare provider or Noven Pharmaceuticals for instructions on how to return the product for a refund.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
231,270

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 #53823
  • Exp 08/12

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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