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. The hazard involves a mechanical defect in the delivery system without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Noven Therapeutics, LLC is recalling 13,761 boxes of Daytrana (methylphenidate) transdermal system patches. The product is a prescription medication that delivers 15 mg of methylphenidate over 9 hours. The recall covers 30-count boxes with NDC 68968-5553-3.
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 lots are 85942 (expiration 03/2020) and 86281 (expiration 06/2020). The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected patches and contact their healthcare provider or Noven Therapeutics for further instructions.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Therapeutics, LLC
- Category
- Drug — Prescription Drug
- Affected units
- 13,761
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#: 85942
- Exp 03/2020
- 86281
- 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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