CLASS II ONGOING Drug recall · Reported 6 Jul 2022 · FDA Enforcement Report
Daytrana (methylphenidate transdermal system) Delivers recalled
Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours 1 mg/hr), distributed nationwide in the US. The recall was initiated on 24 Jun 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-1169-2022
- FDA event ID
- 90506
- Recalling firm
- Noven Pharmaceuticals, Miami, FL
- Brand
- Daytrana
- Manufacturer
- Noven Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2022
- FDA classified
- 29 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 24 Jun 2022 | Recall initiated by company | |
| 29 Jun 2022 | Classified by FDA | +5 days |
| 6 Jul 2022 | Published in enforcement report | +7 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: Customer complaints received for ripping patches and tight release/adhesive transfer.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours 1 mg/hr) recalled?
Yes. Noven Pharmaceuticals recalled Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours 1 mg/hr) on 24 Jun 2022. The recall is Class II and its status is Ongoing. Recall number D-1169-2022.
Why was it recalled?
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Which lots are affected?
Lot: 91272 Exp. 12/22.
Where was it sold?
Distributed 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 |