Daytrana — Class II drug recall D-0394-2021
Ongoing recall by Noven Pharmaceuticals Inc, reported 2021-06-02, distributed nationwide. Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive tr
| Recall number | D-0394-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2021-05-20 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,689 boxes |
| NDC | 68968-5552, 68968-5552-03, 68968-5553, 68968-5553-01, 68968-5553-03, 68968-5554, 68968-5554-03, 68968-5555, 68968-5555-03 |
| Lot numbers | 88530 |
| Expiration dates | 2021-10 |
Product
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Reason for recall
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0394-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.