Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 125,340 Daytrana patches because one lot exceeded the mechanical peel specification. The recall is nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text does not report any illnesses or injuries, indicating a theoretical or low-risk hazard.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 125,340 Daytrana (methylphenidate transdermal system) patches. The affected product is Lot # 73346, with an expiration date of 03/2015. The patches deliver 30 mg of methylphenidate over 9 hours and are distributed nationwide.
The recall was initiated because one lot exceeded the mechanical peel specification, which is a defect in the delivery system. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers should stop using the affected patches and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 125,340
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 # 73346
- Exp 03/2015
Distribution
Distributed nationwide across the United States.
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