Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Therapeutics is recalling Daytrana (methylphenidate) transdermal systems 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 source text describes a mechanical defect without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Noven Therapeutics, LLC is recalling 14,142 30-count boxes of Daytrana (methylphenidate transdermal system) 30 mg. The product is a prescription-only medication distributed nationwide in the US. The recall involves specific lots with expiration dates ranging from July 2020 to January 2021.
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 transdermal patch mechanism.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance. The affected lots are 86355, 86356, 86550, 87348, and 87965.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Therapeutics, LLC
- Category
- Drug — Transdermal Patch
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 (5)
- Lots: 86355 Exp. 07/2020
- 86356 Exp.08/2020
- 86550 Exp. 07/2020
- 87348 Exp. 01/2021
- 87965 Exp. 01/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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- ModerateNoven Recalls Daytrana Patches Due to Defective Delivery System
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