Noven Recalls Daytrana 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 moderate severity.
Plain-English summary
Noven Therapeutics, LLC is recalling 7,469 boxes of Daytrana (methylphenidate transdermal system) patches. The product is a prescription medication that delivers 30 mg of methylphenidate over 9 hours. The recall affects specific lots with expiration dates of May 2020 and June 2020.
The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel and shear. This defect relates to the physical integrity of the patch's delivery mechanism.
The affected product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the recalled patches and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Therapeutics, LLC
- Category
- Drug — Transdermal Patch
- Affected units
- 7,469
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 (4)
- Lot#: 86083
- Exp 05/2020
- 86282
- Exp 06/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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