FDA Drug recall D-0471-2023
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nov…
- FDA Drug
- Class II
- ongoing
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Nov… by Noven Pharmaceuticals, citing defective Delivery System: Out of specification for shear.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0471-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-10 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
Reason
Defective Delivery System: Out of specification for shear.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2023%22
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