CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Daytrana (methylphenidate transdermal system) patches recalled
Noven Therapeutics is recalling Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours 6, distributed nationwide in the US. The recall was initiated on 2 Mar 2020 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-1043-2020
- FDA event ID
- 85128
- Recalling firm
- Noven Therapeutics, Miami, FL
- Brand
- Daytrana
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2020
- FDA classified
- 19 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 2 Mar 2020 | Recall initiated by company | |
| 19 Mar 2020 | Classified by FDA | +17 days |
| 25 Mar 2020 | 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 for mechanical peel and shear.
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) 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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours 6 recalled?
Yes. Noven Therapeutics recalled Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours 6 on 2 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1043-2020.
Why was it recalled?
Defective Delivery System: Out of specification for mechanical peel and shear.
Which lots are affected?
Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020
Where was it sold?
U.S.A. 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 Therapeutics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana | Noven Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana | Noven Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana | Noven Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) patches recalledDaytrana | Noven Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) patches recalledDaytrana | Noven Therapeutics | 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 |