FDA Drug recall D-0008-2016
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therap…
- FDA Drug
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therap… by Noven Pharmaceuticals, citing defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0008-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-27 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Reason
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lot #: 75983, Expiry: 11/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.