Home / Brands / Noven Pharmaceuticals
Noven Pharmaceuticals Recalls
51 recalls on record · June 20, 2012 to November 27, 2024 · Drugs
Recalls by year
12
13
14
15
16
17
18
21
22
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 27, 2024DrugsFDA
Noven Pharmaceuticals Inc recalls Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal p
Hazard: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
March 29, 2023DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,
Hazard: Defective Delivery System: Out of specification for shear.
December 7, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Ma
Hazard: 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.
July 6, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Man
Hazard: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
June 1, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Man
Hazard: Defective Delivery System: customer complaints exceeded respective action limits.
August 25, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Sy
Hazard: Failed Stability Specifications; out of specification for shear.
August 25, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2
Hazard: Failed Stability Specifications; out of specification for shear.
June 2, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) pe
Hazard: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
June 2, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) pe
Hazard: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
April 28, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami,
Hazard: Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
April 28, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals,
Hazard: Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sea
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sea
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foi
Hazard: Defective Delivery System: Out of specification for mechanical peel.
March 10, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-s
Hazard: Defective Delivery System: Out of specification for mechanical peel.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmace
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmace
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by:
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. b
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
May 16, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per
Hazard: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
May 16, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per bo
Hazard: Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
April 25, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 6
Hazard: Defective Delivery System: Out of specification for adhesive transfer.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
September 27, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manu
Hazard: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
July 5, 2017DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeu
Hazard: Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.