The Recall Desk
ModerateFDA (Drugs)·D-1044-2020·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.

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 hazard involves a mechanical defect in the delivery system without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Noven Therapeutics, LLC is recalling 11,093 boxes of Daytrana (methylphenidate transdermal system) patches. The affected product is the 20 mg over 9 hours (2.2 mg/hr) strength, 30-count box, with NDC 68968-5554-3. The recall covers lots 86081 (Exp 04/2020) and 86196 (Exp 06/2020), which were distributed nationwide in the U.S.A.

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.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot numbers and expiration dates listed above.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Therapeutics, LLC
Category
Drug — Transdermal Patch
Hazard
Affected units
11,093

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)

  • Lo#t: 86081
  • Exp 04/2020
  • 86196
  • 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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