PlainRecordsBrand recall history
Noven Pharmaceuticals recalls
Every FDA recall record we found for Noven Pharmaceuticals, newest first. Updated Oct. 11, 2026.
25
25 recalls since 2012. The most recent was on Nov. 27, 2024.
- Last 12 months
- 0
- Most recent
- 2024-11
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2012–2026121314151617181920212223242526
Class I (FDA, most serious)Other recalls
All recalls
25- Nov. 27, 2024Xelstrym (dextroamphetamine) transdermal system… Class IIDefective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- March 29, 2023Daytrana (methylphenidate transdermal system) CII… and 3 more products Class IIDefective Delivery System: Out of specification for shear.
- Dec. 7, 2022Daytrana (methylphenidate transdermal system)… Class IIDefective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of…
- July 6, 2022Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches… Class IIDefective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
- June 1, 2022Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches… Class IIDefective Delivery System: customer complaints exceeded respective action limits.
- Aug. 25, 2021Combipatch (estradiol/norethindrone acetate transdermal system)… and 1 more product Class IIFailed Stability Specifications; out of specification for shear.
- June 2, 2021Daytrana (methylphenidate transdermal system)… and 1 more product Class IIDefective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- April 28, 2021Minivelle (estradiol transdermal system) Delivers 0.075 mg/day… and 1 more product Class IIDefective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the…
- March 10, 2021Daytrana (methylphenidate transdermal system)… and 3 more products Class IIDefective Delivery System: Out of specification for mechanical peel.
- Oct. 3, 2018Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day… and 3 more products Class IIDefective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- May 16, 2018Minivelle (estradiol transdermal system) 0.1 mg/day… and 1 more product Class IIDefective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches.…
- April 25, 2018Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx… Class IIDefective Delivery System: Out of specification for adhesive transfer.
- Sept. 27, 2017Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9… and 3 more products Class IIDefective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- July 5, 2017Minivelle (estradiol Transdermal System) 0.1 mg per day… Class IIIDefective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
- Jan. 18, 2017Daytrana (methylphenidate transdermal system) Transdermal Patch… and 2 more products Class IIDefective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
- July 20, 2016Daytrana (methylphenidate transdermal system) Transdermal Patch… and 2 more products Class IIDefective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…
- Oct. 14, 2015Daytrana (methylphenidate transdermal system)… Class IIDefective Delivery System: Out of specification for z-statistic related to mechanical peel force.
- June 3, 2015Daytrana (methylphenidate transdermal system)… Class IIDefective Delivery System: One lot exceeded the mechanical peel specification
- April 22, 2015Minivelle (estradiol transdermal system) 0.05 mg/day… Class IITemperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- Oct. 1, 2014Daytrana (methylphenidate transdermal system) patch… Class IIDefective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…
- March 26, 2014Daytrana (methylphenidate) transdermal system patch… and 1 more product Class IIDefective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
- May 8, 2013Daytrana (methylphenidate) transdermal system patch… Class IIDefective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
- Aug. 29, 2012Daytrana (methylphenidate) transdermal system patch… and 2 more products Class IIMiscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to…
- July 18, 2012Daytrana (Methylphenidate) Transdermal System Patch… Class IIMiscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
- June 20, 2012Daytrana (methylphenidate) transdermal system patch… and 3 more products Class IIMiscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to…
No recalls match.
How we match: a recall is listed here when the agency names Noven Pharmaceuticals as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.