The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0295-2021·Announced 2021-03-10

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 786,900 Daytrana (methylphenidate) patches 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 hazard is a mechanical defect (out of specification for mechanical peel) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Noven Pharmaceuticals Inc. is recalling 786,900 units of Daytrana (methylphenidate) transdermal systems. The affected product is a prescription medication that delivers 20 mg of methylphenidate over 9 hours. The recall covers specific lots with expiration dates ranging from April 2021 to July 2021.

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 application mechanism. The affected patches were distributed nationwide in the United States.

Consumers and healthcare providers should stop using the affected Daytrana patches and contact their healthcare provider for a replacement or alternative treatment. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Prescription Transdermal
Hazard
Affected units
786,900

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 (9)

  • Lots #: 87580
  • Exp 4/2021
  • 87819
  • 88244
  • Exp 6/2021
  • 88245
  • 88532
  • Exp 06/2021 & 88533
  • 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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