The Recall Desk
HighFDA (Drugs)·D-0471-2023·Announced 2023-03-29

Daytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System

Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal patches due to a defective delivery system that is out of specification for shear. Affected lots are Lot 91956 (6/2023) and Lot 92475 (7/2023), 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 a Class II FDA recall for a manufacturing defect in a drug delivery system. As the source does not document reported illnesses or injuries, and the defect is manufacturing-related, the recall meets the criteria for High (3) severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Noven Pharmaceuticals Inc is recalling certain lots of Daytrana (methylphenidate) transdermal patches, 15 mg strength, 30-count cartons (NDC 68968-5553-3). The affected lots include Lot 91956 (expiration 6/2023) and Lot 92475 (expiration 7/2023), which were distributed nationwide.

The product is being recalled because the transdermal delivery system is out of specification for shear.

This is a Class II FDA recall, issued under the Food and Drug Administration's Drug Recalls program.

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 (4)

  • Lot#: 91956
  • Exp. 6/2023
  • 92475
  • Exp. 7/2023

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

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Same hazard · delivery defect

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