Daytrana — Class II drug recall D-312-2013
Terminated recall by Noven Pharmaceuticals, Inc., reported 2013-05-08, distributed nationwide. Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the
| Recall number | D-312-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2013-01-31 |
| Classified | 2013-05-02 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2016-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 335,910 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 | 04/13, 59824 |
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Reason for recall
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
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-312-2013. 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.