The Recall Desk
ModerateFDA (Drugs)·D-1372-2012·Announced 2012-06-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 357,510 Daytrana (methylphenidate) patches because the delivery system may be miscalibrated or defective, affecting the ability to remove the release liner.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect affects the ease of removing the liner, which is a functional issue rather than a direct chemical contamination or structural failure leading to severe injury.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 357,510 Daytrana (methylphenidate) transdermal system patches. The recall involves two specific lots: Lot 49203 (Expiration 10/12) and Lot 50265 (Expiration 01/13). The affected products are packaged in 30-count boxes and are labeled for distribution by Shire US Inc. and Noven Therapeutics, LLC.

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 issue is described as a miscalibrated and/or defective delivery system.

The affected patches were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
357,510

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 #'s: a) 49203
  • Exp 10/12
  • b) 50265
  • Exp 01/13

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 brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · defective delivery system

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