Daytrana — Class II drug recall D-1413-2012
Terminated recall by Noven Pharmaceuticals, Inc., reported 2012-07-18, distributed nationwide. Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/o
| Recall number | D-1413-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2012-03-22 |
| Classified | 2012-07-12 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2014-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 185,160 patches |
| NDC | 68968-5552, 68968-5552-03, 68968-5553, 68968-5553-03, 68968-5554, 68968-5554-01, 68968-5554-03, 68968-5555, 68968-5555-03 |
| Lot numbers | 53995 |
Product
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Reason for recall
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
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-1413-2012. 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.