The Recall Desk
ModerateFDA (Drugs)·D-0627-2018·Announced 2018-04-25

Noven Recalls Daytrana Methylphenidate Patches Due to Adhesive Defect

Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the adhesive transfer is out of specification.

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 defect is a manufacturing issue (adhesive transfer) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 9,016 boxes of Daytrana (methylphenidate) transdermal system patches. The product is a prescription medication that delivers 10 mg of methylphenidate over 9 hours. The specific lot number is 82237, with an expiration date of May 31, 2018.

The recall was initiated because the product's delivery system is defective, specifically being out of specification for adhesive transfer. This defect may affect the patch's ability to adhere properly to the skin as intended.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled patches and contact their healthcare provider or Noven Pharmaceuticals for further instructions.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard

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 #: 82237 Exp. May 31
  • 2018

Distribution

Distributed nationwide across the United States.

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Same hazard · adhesive defect

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