The Recall Desk
ModerateFDA (Drugs)·D-1171-2014·Announced 2014-03-26

Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling 187,860 Daytrana patches because the release liner may be difficult to remove. The defect affects the ability to apply the patch correctly.

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 hazard involves a functional defect in the delivery system (liner removal) rather than a direct toxicological or structural safety failure. No injuries or illnesses are reported in the source text.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 187,860 units of Daytrana (methylphenidate) transdermal system patches. The product is a prescription medication that delivers 20 mg of methylphenidate over 9 hours. The specific lot affected is #69618 with an expiration date of 09/14. The patches were distributed nationwide.

The recall was initiated due to out-of-specification results for the z-statistic value. This metric relates to the ability of patients and caregivers to remove the release liner from the patch adhesive prior to administration. The defect may make it difficult to properly prepare the patch for use.

Consumers with this specific lot of Daytrana patches should stop using them and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
DAYTRANA (METHYLPHENIDATE)
Brand
DAYTRANA
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Prescription Transdermal Patch
Hazard
Affected units
187,860

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 #69618
  • Exp. 09/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 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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