Daytrana — Class II drug recall D-0429-2017
Terminated recall by Noven Pharmaceuticals, Inc., reported 2017-01-18, distributed nationwide. Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or t
| Recall number | D-0429-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2016-08-22 |
| Classified | 2017-01-10 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2019-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 364,830 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 | 77547, 79230 |
| Expiration dates | 2016-07, 2017-02 |
Product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Reason for recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
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-0429-2017. 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.