CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report
Daytrana (methylphenidate transdermal system) Transdermal recalled
Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours 2, distributed nationwide in the US. The recall was initiated on 21 Dec 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1439-2016
- FDA event ID
- 73718
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Daytrana
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2015
- FDA classified
- 14 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 21 Dec 2015 | Recall initiated by company | |
| 14 Jul 2016 | Classified by FDA | +206 days |
| 20 Jul 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Where it was distributed
Nationwide
Questions about this recall
Is Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours 2 recalled?
Yes. Noven Pharmaceuticals recalled Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours 2 on 21 Dec 2015. The recall is Class II and its status is Terminated. Recall number D-1439-2016.
Why was it recalled?
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Which lots are affected?
Lot # 77140, Exp 05/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Noven Pharmaceuticals
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xelstrym (dextroamphetamine) transdermal system recalledXelstrym | Noven Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
Other Methylphenidate recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg recalledMethylphenidate Hydrochloride | Trigen Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylphenidate Hydrochloride Tablets, USP 20mg recalledMethylphenidate Hydrochloride | Sun Pharmaceutical Industries | Foreign Material | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |