CLASS II ONGOING Drug recall · Reported 7 Dec 2022 · FDA Enforcement Report
Daytrana (methylphenidate transdermal system) recalled
Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, 6 mg/hr), 30, distributed nationwide in the US. The recall was initiated on 16 Nov 2022 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-0071-2023
- FDA event ID
- 91161
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Daytrana
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Nov 2022
- FDA classified
- 28 Nov 2022
- Reported
- 7 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 16 Nov 2022 | Recall initiated by company | |
| 28 Nov 2022 | Classified by FDA | +12 days |
| 7 Dec 2022 | Published in enforcement report | +9 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: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
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), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, 6 mg/hr), 30 recalled?
Yes. Noven Pharmaceuticals recalled Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, 6 mg/hr), 30 on 16 Nov 2022. The recall is Class II and its status is Ongoing. Recall number D-0071-2023.
Why was it recalled?
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Which lots are affected?
Lot: 91316 Exp. 02/2023
Where was it sold?
Nationwide in the USA
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 |