Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 473,280 Daytrana (methylphenidate) patches because the delivery system failed mechanical peel 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 rating.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling 473,280 patches of Daytrana (methylphenidate transdermal system). The product is a prescription medication that delivers 10 mg of methylphenidate over 9 hours. The recalled items are packaged in foil-sealed polypropylene trays within paper cartons.
The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel. This defect affects the integrity of the patch delivery mechanism. The affected lots are 87579 (expiring 3/2021) and 88243 (expiring 7/2021).
The recalled patches were distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or Noven Pharmaceuticals for further instructions.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Affected units
- 473,280
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 (3)
- Lots #: 87579
- Exp 3/2021 & 88243
- Exp 7/2021.
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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