Noven Pharmaceuticals, Inc.

Complete recall history across all FDA and CPSC categories — 33 total recalls

Noven Pharmaceuticals, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (33)

FDA drug safety enforcement actions by Noven Pharmaceuticals, Inc.

Date Product Reason Class
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 ... Defective Delivery System: out of specification results for shear, an attribu... Class II
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribu... Class II
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 co... Defective Delivery System: out of specification results for shear, an attribu... Class II
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribu... Class II
May 4, 2018 Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (N... Defective Delivery System: no longer meets the specification for shear, an at... Class II
May 4, 2018 Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC ... Defective Delivery System: no longer meets the specification for shear, an at... Class II
Apr 9, 2018 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Out of specification for adhesive transfer. Class II
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Products no longer meet the release liner removal ... Class II
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.... Defective Delivery System: Products no longer meet the release liner removal ... Class II
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Products no longer meet the release liner removal ... Class II
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Products no longer meet the release liner removal ... Class II
Apr 27, 2017 Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... Defective Delivery System: Out of specification for peel force from the relea... Class III
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Jul 27, 2015 Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3... Defective Delivery System: Out of specification for z-statistic related to me... Class II
Feb 25, 2015 Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, M... Temperature Abuse: Prolonged exposure to temperatures outside of labeled stor... Class II
Jan 12, 2015 Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3... Defective Delivery System: One lot exceeded the mechanical peel specification Class II
Jul 15, 2014 Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the mechani... Class II
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-stati... Class II
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-stati... Class II
Jan 31, 2013 Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-stati... Class II
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Mar 22, 2012 Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 ho... Miscalibrated/Defective Delivery System; exceeded the specification for both ... Class II
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.