Daytrana Methylphenidate Patches Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) 30 mg patches due to a defective delivery system that failed mechanical peel force 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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The defect is a mechanical specification failure without reported injuries or deaths, fitting the Moderate severity criteria.
Plain-English summary
Noven Pharmaceuticals, Inc. is recalling 125,250 units of Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches. The affected product is identified by Lot # 75983 and has an expiration date of 11/15. The recall is limited to the 30 mg strength and the specific NDC 68968-5555-3.
The recall was initiated because the product's delivery system was found to be out of specification for the z-statistic related to mechanical peel force. This defect relates to the mechanical integrity of the patch delivery system.
The affected patches were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 125,250
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 (2)
- Lot #: 75983
- Expiry: 11/15
Distribution
Distributed nationwide across the United States.
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