Daytrana — Class II drug recall D-1373-2012
Terminated recall by Noven Pharmaceuticals, Inc., reported 2012-06-20, distributed nationwide. Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or
| Recall number | D-1373-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals, Inc., Miami, FL, United States |
| Recall initiated | 2011-07-05 |
| Classified | 2012-06-14 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2013-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 242,100 patches |
| Reason classes | specification failure |
| NDC | 54092-0555-01, 54092-0555-30 |
| Lot numbers | 01/12, 10/12, 43008, 48591 |
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
Reason for recall
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
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-1373-2012. 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.