The Recall Desk
ModerateFDA (Drugs)·D-1248-2020·Announced 2020-04-29

Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System

Noven Therapeutics is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed mechanical peel and shear specifications.

What this means for you

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: The recall is classified as FDA Class II, and the defect is a mechanical specification failure without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Noven Therapeutics, LLC is recalling 5,614 30-count boxes of Daytrana (methylphenidate transdermal system) 20 mg. The affected product is Lot 86354 with an expiration date of 08/2020. The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel and shear.

The recalled product was distributed nationwide in the United States. Daytrana is a prescription-only medication used to treat attention deficit hyperactivity disorder (ADHD). The specific NDC for the recalled 30-count box is 68968-5554-3.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be removed from use and returned to the distributor or Noven Therapeutics for further instructions.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Therapeutics, LLC
Category
Drug — Prescription Transdermal
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 (1)

  • Lot: 86354 Exp. 08/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Noven Therapeutics, LLC 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 3 products in this recall →

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Therapeutics, LLC

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Same hazard · defective delivery system

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