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.
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