The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0294-2021·Announced 2021-03-10

Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 551,670 Daytrana methylphenidate patches nationwide because the delivery system failed mechanical peel 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 voluntary precautionary recall.

Plain-English summary

Noven Pharmaceuticals Inc. is recalling 551,670 units of Daytrana (methylphenidate) transdermal patches. The affected product is a prescription medication that delivers 15 mg of methylphenidate over 9 hours. The recall covers specific lots with expiration dates in April, May, and July 2021, which were distributed nationwide in the United States.

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

Consumers and healthcare providers with the affected Daytrana patches should stop using them and contact their healthcare provider or Noven Pharmaceuticals for further instructions on how to return or dispose of the product.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Prescription Transdermal Patch
Hazard
Affected units
551,670

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 (5)

  • Lots #: 87818
  • Exp 4/2021
  • 88274
  • Exp 5/2021 & 88531
  • Exp 7/2021.

Distribution

Distributed nationwide across the United States.

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 →

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