The Recall Desk
HighFDA (Drugs)·D-0472-2023·Announced 2023-03-29

Daytrana methylphenidate patches recalled for defective delivery system

Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches for a defective delivery system that fails to meet shear specifications. The recall affects specific lots distributed nationwide.

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 is an FDA Class II drug recall for a prescription CNS stimulant with a defective delivery system. The hazard is a risk-of-harm product (a controlled substance where delivery system integrity directly affects patient safety), with no illnesses or injuries reported in the source material.

Plain-English summary

Noven Pharmaceuticals Inc is recalling specific lots of Daytrana (methylphenidate) 20mg transdermal patches due to a defective delivery system. The patches are out of specification for shear, meaning they do not meet the required structural standards for the transdermal delivery system.

The affected lots are: 91957 and 92197 (expiring 7/2023); 92476 (expiring 9/2023); and 92477 (expiring 10/2023). These patches were distributed nationwide.

Daytrana is a prescription medication used to treat attention-deficit/hyperactivity disorder. A defective delivery system could affect proper absorption and delivery of the medication. Patients using Daytrana should check if they have patches from the affected lots and contact their pharmacy or healthcare provider with questions.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals Inc
Category
Drug — 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 (7)

  • Lot#: 91957
  • 92197
  • Exp. 7/2023
  • 92476
  • Exp. 9/2023
  • 92477
  • 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 →

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