Methylphenidate Patch Recall: Defective Delivery System and Adhesive Issues
Daytrana (methylphenidate) patches are being recalled due to ripping patches and poor adhesive transfer affecting drug delivery. This Class II recall involves 8,559 cartons distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription drug with a defective delivery system that poses a risk of improper medication delivery. No illnesses or injuries have been reported, but the defect represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for High severity.
Plain-English summary
Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate transdermal system) patches that deliver 10 mg over 9 hours due to defects in the patch delivery system.
Customer complaints have been received regarding patches that rip during application or wear, and patches that have poor adhesive transfer, which can affect the proper delivery of the medication to the skin.
The recall affects Lot 91272 with expiration date 12/22, totaling 8,559 cartons. The product was distributed nationwide in the United States. Daytrana is a prescription medication containing methylphenidate, a central nervous system stimulant.
Patients taking this medication should consult their healthcare provider or pharmacist if they have patches from the affected lot. Do not discontinue use without medical guidance. Healthcare providers should check their inventory and contact their suppliers about the recall.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Hazard
- defective-patch
- adhesive-failure
- improper-delivery
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: 91272 Exp. 12/22.
Distribution
Distributed nationwide across the United States.
Related recalls
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- HighDaytrana 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
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- ModerateDaytrana Methylphenidate Patches Recalled for Defective Delivery System
FDA (Drugs) · 2023-03-29
- HighDaytrana transdermal methylphenidate patches recalled for adhesive defect
FDA (Drugs) · 2022-12-07
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