The Recall Desk
ModerateFDA (Drugs)·D-1375-2012·Announced 2012-06-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 335,190 Daytrana 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, and the defect involves a mechanical issue with removing the release liner rather than a direct chemical contamination or high-risk pathogen, fitting the criteria for moderate severity.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 335,190 units of Daytrana (methylphenidate) transdermal system patches. The affected product is the 10 mg over 9 hours (1.1 mg/hr) strength, packaged in 30-count boxes (NDC 54092-552-30). The recall covers Lot #41843 with an expiration date of 11/11.

The recall was initiated due to miscalibrated and/or defective delivery systems. Specifically, the patches failed to meet specifications 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 and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
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.,
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
335,190

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 #: 41843
  • Exp 11/11

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.

See all →

Same hazard · defective delivery system

See all →