Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because customer complaints regarding ripped patches and adhesive transfer 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, but the source text does not report any illnesses or injuries, and the defect is mechanical (ripping/adhesive) rather than a high-risk pathogen or structural failure causing harm.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling 6,689 boxes of Daytrana (methylphenidate transdermal system), 15 mg over 9 hours (1.6 mg/hr), 30 patches per box. The affected product is identified by Lot 88530 with an expiration date of 10/2021. 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/adhesive transfer exceeded the established action limits. The source text does not report any illnesses or injuries associated with this defect.
Consumers should stop using the recalled patches and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Category
- Drug — Transdermal Patch
- Affected units
- 6,689
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: 88530 Exp. 10/2021
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
- ModerateDaytrana Methylphenidate Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana methylphenidate patches recalled for defective delivery system
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- HighDaytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
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- 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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