FDA Drug recall D-1249-2020
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therape…
- FDA Drug
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therape… by Noven Therapeutics, citing defective Delivery System: Out of specification for mechanical peel and shear.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1249-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-31 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Therapeutics |
| Distribution | US |
Product
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1249-2020%22
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