The Recall Desk
ModerateFDA (Drugs)·D-1438-2016·Announced 2016-07-20

Noven Recalls Daytrana Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 7,850 boxes of Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.

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 FDA classified this as a Class II recall. The hazard involves a mechanical defect in the delivery system (difficulty removing the liner) rather than a chemical contamination or serious injury risk, fitting the criteria for moderate severity.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 7,850 boxes of Daytrana (methylphenidate) transdermal patches, 15 mg over 9 hours. The affected product is identified by Lot # 77303 with an expiration date of 06/16. The recall is due to out-of-specification results for the mechanical peel force and z-statistic value, which relate to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration.

The recall covers product distributed nationwide. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers should stop using the affected patches and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
7,850

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 (2)

  • Lot #: 77303
  • Exp 06/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same brand · DAYTRANA

Same manufacturer · Noven Pharmaceuticals, Inc.

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Same hazard · defective delivery system

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