Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because customer complaints regarding ripped patches and adhesive issues exceeded action limits.
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 defective delivery system (ripping/adhesive issues) without reported injuries or illnesses, fitting the criteria for moderate severity involving product defects without immediate serious harm.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling 9,587 boxes of Daytrana (methylphenidate transdermal system) patches. The affected product is the 10 mg over 9 hours (1.1 mg/hr) strength, packaged as 30 patches per box. The specific lot number is 88528 with an expiration date of 09/2021. The product was distributed nationwide in the USA.
The recall was initiated due to a defective delivery system. The number of customer complaints regarding ripped patches and tight release or adhesive transfer exceeded the established action limits. This issue affects the physical integrity of the patch delivery mechanism rather than the chemical composition of the drug.
Consumers who have this specific lot of Daytrana patches should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as Class II by the FDA.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Category
- Drug — Transdermal Patch
- Affected units
- 9,587
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 (1)
- Lot: 88528 Exp. 09/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same brand · DAYTRANA
- HighDaytrana methylphenidate patches recalled for defective delivery system
FDA (Drugs) · 2023-03-29
- ModerateDaytrana Methylphenidate Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana transdermal methylphenidate patches recalled for adhesive defect
FDA (Drugs) · 2022-12-07
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