The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0473-2023·Announced 2023-03-29

Daytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System

Noven Pharmaceuticals recalls Daytrana (methylphenidate) 30 mg transdermal patches nationwide due to defective delivery system components that fail shear specifications. Patients should contact their healthcare provider regarding medication alternatives.

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 3/5 (High).

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 is an FDA Class II recall without reported hospitalizations or illnesses. The defective delivery system of a prescription CNS stimulant represents a risk-of-harm scenario with no documented patient harm, meeting the High severity criterion.

Plain-English summary

Noven Pharmaceuticals Inc has issued a nationwide recall of Daytrana (methylphenidate) 30 mg transdermal patches. Multiple manufacturing lots are affected, with expiration dates ranging from March 2023 through October 2023.

The recall was initiated because the delivery system in these patches does not meet specifications for shear. This defect could compromise the patches' ability to adhere properly and deliver the prescribed dose of methylphenidate.

Daytrana is a prescription medication used to treat attention-deficit/hyperactivity disorder (ADHD). Patients currently using affected patches should contact their prescribing healthcare provider to discuss their medication options and obtain alternative treatment if necessary.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Prescription Transdermal Patch
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 (14)

  • Lot#: 91474
  • 91959
  • Exp. 3/2023
  • 91958
  • Exp. 6/2023
  • 92478
  • Exp. 7/2023
  • 92479 & 92198
  • Exp. 8/2023
  • 92199
  • 93040
  • Exp. 9/2023
  • 93041
  • Exp. 10/2023.

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 →

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals Inc

See all →

Same hazard · defective delivery system

See all →

Similar recalls