The FDA announced on May 20, 2021, that Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate transdermal system) patches due to a defective delivery system. The agency stated the recall affects 9,587 boxes distributed nationwide.
How to tell if you have it
- Brand: Noven
- Product: Daytrana (methylphenidate transdermal system)
- Dosage: Delivers 10 mg over 9 hours (1.1 mg/hr)
- Quantity per box: 30 Patches
- NDC: 68968-5552-1 (per patch), 68968-5552-3 (per box)
- Lot code: 88528
- Expiration date: 09/2021
The hazard
According to the FDA, customer complaints for ripping patches and tight release/adhesive transfer have exceeded action limits. The recall is classified as a Class II voluntary firm-initiated recall.
Context
GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since July 5, 2011. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024), Noven Daytrana 10mg Transdermal System Recall (March 10, 2023), and Noven Daytrana patches recalled due to defective adhesive delivery (Nov. 16, 2022). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), Preferred Pharma Recalls Ondansetron ODT Due to Defective Seals (Nov. 17, 2025), and Gold Star Distribution EXCEDRIN MIGRA: Recall due to unsanitary conditions (Dec. 26, 2025).