The Recall Desk
HighFDA (Drugs)·D-0889-2022·Announced 2022-06-01

Prescription Drug Daytrana Patches Recalled for Defective Delivery System

Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches from Lot 90764 (expiration 08/2022) distributed nationwide due to defects in the delivery system. The recall was initiated after customer complaints exceeded FDA action limits.

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: This recall involves a prescription drug with a defective delivery system that poses a risk of improper medication delivery. No illnesses or injuries are reported, which limits the score to 3 per the rubric. FDA Class II classification without hospitalization reports confirms this severity level.

Plain-English summary

Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate) transdermal patches from Lot 90764 (expiration 08/2022) that were distributed nationwide. The recall was issued due to defects in the patch delivery system.

Customer complaints regarding the delivery system defect exceeded the FDA's action limits, triggering the recall. The specific nature of the defects is not detailed in the recall notice, nor are any adverse health events reported.

Patients who received Daytrana patches from the affected lot should consult their healthcare provider. Healthcare providers and patients should not use patches from the affected lot.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Transdermal Patch
Hazard
  • delivery-system-defect
  • dosing-error

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: 90764 Exp. 08/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DAYTRANA

Same category