The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1042-2020·Announced 2020-03-25

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Therapeutics is recalling Daytrana (methylphenidate) patches because the delivery system failed mechanical peel and shear specifications.

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 defect is a mechanical specification failure without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Noven Therapeutics, LLC is recalling 9,513 boxes of Daytrana (methylphenidate transdermal system) patches. The affected product is the 10 mg over 9 hours (1.1 mg/hr) strength, 30-count box, with NDC 68968-5552-3. The specific lot number is 86280, with an expiration date of 06/2020.

The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel and shear. This defect relates to the physical integrity of the transdermal patch mechanism.

The affected product was distributed nationwide in the U.S.A. Consumers and healthcare providers should stop using the recalled patches and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Therapeutics, LLC
Category
Drug — Transdermal Patch
Hazard
Affected units
9,513

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#: 86280
  • Exp 06/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Noven Therapeutics, LLC 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 →

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