Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 551,670 Daytrana methylphenidate patches nationwide 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 defect is a mechanical specification failure without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling 551,670 units of Daytrana (methylphenidate) transdermal patches. The affected product is a prescription medication that delivers 15 mg of methylphenidate over 9 hours. The recall covers specific lots with expiration dates in April, May, and July 2021, which were distributed nationwide in the United States.
The recall was initiated because the product's delivery system was found to be out of specification for mechanical peel. This defect relates to the physical integrity of the patch's delivery mechanism.
Consumers and healthcare providers with the affected Daytrana patches should stop using them and contact their healthcare provider or Noven Pharmaceuticals for further instructions on how to return or dispose of the product.
The recalled product
- Product
- DAYTRANA (METHYLPHENIDATE)
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals Inc
- Affected units
- 551,670
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 (5)
- Lots #: 87818
- Exp 4/2021
- 88274
- Exp 5/2021 & 88531
- 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
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
Same manufacturer · Noven Pharmaceuticals Inc
See all →- HighPrescription Dextroamphetamine Patches Recalled for Defective Adhesive System
FDA (Drugs) · 2024-11-27
- HighMethylphenidate Patch Recall: Defective Delivery System and Adhesive Issues
FDA (Drugs) · 2022-07-06
Same hazard · defective delivery system
See all →- ModerateCetrorelix injection kits recalled over missing or duplicated needles inside
FDA (Drugs) · 2026-02-18
- HighAIRSUPRA Albuterol and Budesonide Inhalation Aerosol Recalled for Defective Delivery System
FDA (Drugs) · 2025-05-28
- HighLorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
FDA (Drugs) · 2025-03-12
- ModerateVarithena Administration Pack Recalled Due to Incorrect Syringe Connector Type
FDA (Drugs) · 2024-12-18
- ModerateDrug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits
FDA (Drugs) · 2022-08-24