Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because they no longer meet release liner removal 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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling Daytrana (methylphenidate) transdermal systems, a prescription medication used to treat attention deficit hyperactivity disorder (ADHD). The recall involves 331,950 patches distributed nationwide. The specific lots affected are 80442 (Exp. 10/17), 80439 (Exp. 08/17), and 80438 (Exp. 08/17).
The recall was initiated because the products no longer meet the release liner removal specification and/or z-statistic. This defect in the delivery system may affect the performance of the transdermal patch. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected Daytrana patches and contact their healthcare provider for guidance on alternative treatment options. The recalling firm, Noven Pharmaceuticals, Inc., is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Affected units
- 331,950
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: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
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
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