Daytrana — Class II drug recall D-0296-2021
Terminated recall by Noven Pharmaceuticals Inc, reported 2021-03-10, distributed nationwide. Defective Delivery System: Out of specification for mechanical peel.
| Recall number | D-0296-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2021-02-19 |
| Classified | 2021-03-03 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2024-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 934,140 patches |
| Reason classes | specification failure |
| NDC | 68968-5552, 68968-5552-03, 68968-5553, 68968-5553-03, 68968-5554, 68968-5554-03, 68968-5555, 68968-5555-03 |
| Lot numbers | 87377, 87572, 87581, 87820, 88246, 88535, 88536, 88537, 88939 |
| Expiration dates | 2021-03, 2021-04, 2021-05, 2021-06, 2021-07, 2021-08 |
Product
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.
Reason for recall
Defective Delivery System: Out of specification for mechanical peel.
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-0296-2021. 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.