The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1172-2014·Announced 2014-03-26

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because out-of-specification results indicate the release liner may be difficult to remove.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 functional defect in the delivery system (liner removal) rather than a direct toxicological or structural safety risk, fitting the criteria for moderate severity.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 117,600 Daytrana (methylphenidate) transdermal system patches. The recall affects Lot #70132, which has an expiration date of 09/14. The product is a prescription-only medication packaged in 30-count boxes, distributed nationwide.

The recall was initiated due to out-of-specification (OOS) results for the z-statistic value. This metric relates to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration. The defect may make it difficult to properly prepare the patch for use.

Consumers who have this specific lot of Daytrana should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Prescription Transdermal
Hazard
Affected units
117,600

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 #70132
  • Exp. 09/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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