FDA Drug recall D-1169-2022
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven…
- FDA Drug
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven… by Noven Pharmaceuticals, citing defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1169-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-24 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3
Reason
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Identifiers
| ndc | 68968-5552-3 |
|---|---|
| ndc | 68968-5553-3 |
| ndc | 68968-5554-3 |
| ndc | 68968-5555-3 |
| code_info | Lot: 91272 Exp. 12/22. |
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-1169-2022%22
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