Drug recall: Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, M
FDA enforcement event 85128 is a drug recall by Noven Therapeutics, LLC of Miami, FL, initiated 2 Mar 2020 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 18 May 2023. Initiation: voluntary: firm initiated. Noven Therapeutics, LLC has 2 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Noven Therapeutics, LLC, Miami, FL.
Reason for recall
"Defective Delivery System: Out of specification for mechanical peel and shear."
Distribution
"U.S.A. Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1042-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3 | 9513 boxes | Class II | Terminated | 25 Mar 2020 |
| D-1043-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3 | 13761 boxes | Class II | Terminated | 25 Mar 2020 |
| D-1044-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3 | 11093 boxes | Class II | Terminated | 25 Mar 2020 |
| D-1045-2020 | Daytrana (methylphenidate transdermal system) patches, 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 | 7469 boxes | Class II | Terminated | 25 Mar 2020 |
Context
Other enforcement events for Noven Therapeutics, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Mar 2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactur | Drug | Class II | 3 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Delivery System: Out of specification for mechanical peel and shear."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.A. Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 May 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.