The Recall Desk
HighFDA (Drugs)·D-0071-2023·Announced 2022-12-07

Daytrana transdermal methylphenidate patches recalled for adhesive defect

Noven Pharmaceuticals recalls 3,977 boxes of Daytrana methylphenidate transdermal patches nationwide due to defective adhesive properties in lot 91316. Affected patches may fail to adhere properly or deliver medication inconsistently.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting drug delivery system function without reported adverse events. The defective adhesive represents a risk-of-harm product where inconsistent stimulant drug delivery could occur, but no injuries or illnesses have been reported to date.

Plain-English summary

Noven Pharmaceuticals Inc is recalling 3,977 boxes of Daytrana (methylphenidate) 15 mg transdermal patches distributed nationwide. The recalled lot (91316, expiring 02/2023) was manufactured out of specification for shear, an attribute that determines the adhesive properties of the patches.

Defects in the adhesive system could cause patches to fail to adhere properly to skin or result in inconsistent drug delivery. Methylphenidate is a central nervous system stimulant medication delivered via transdermal patch.

Consumers should contact their healthcare provider or pharmacist immediately if they have medication from the recalled lot. Patients should not stop taking their medication without consulting their healthcare provider. Healthcare providers should discuss alternative medication options with affected patients.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Transdermal Patch / CNS Stimulant
Hazard
  • adhesive-defect
  • defective-delivery-system

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 (1)

  • Lot: 91316 Exp. 02/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DAYTRANA

Same category