The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0470-2023·Announced 2023-03-29

Daytrana Methylphenidate Patches Recalled for Defective Delivery System

Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect in the delivery system specification, a product quality issue rather than a direct safety threat to patient health.

Plain-English summary

Noven Pharmaceuticals Inc is recalling specific lots of Daytrana (methylphenidate transdermal system) 10mg patches due to a defective delivery system that is out of specification for shear.

The affected lots are #91955 (expiration 7/2023) and #93039 (expiration 10/2023). Distribution was nationwide in the United States. Package NDC is 68968-5552-3.

Patients using Daytrana patches should verify the lot number on their medication carton. Those with patches from the affected lots should contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — Transdermal / Prescription Stimulant
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 (4)

  • Lot#: 91955
  • Exp. 7/2023
  • 93039
  • 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 · drug delivery failure

See all →

Similar recalls