Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Miami, FL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2026 · 11 inspections, 2 with FDA action |
Recalls
- Mar 10, 2023 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for shear.
Lots: Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023 - Mar 10, 2023 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for shear.
Lots: Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023 - Mar 10, 2023 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for shear.
Lots: Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023 - Mar 10, 2023 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for shear.
Lots: Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023. - Nov 16, 2022 · Class II · Noven Pharmaceuticals Inc
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.
Lots: Lot: 91316 Exp. 02/2023 - Jun 24, 2022 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Lots: Lot: 91272 Exp. 12/22. - May 6, 2022 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: customer complaints exceeded respective action limits.
Lots: Lot: 90764 Exp. 08/2022 - May 20, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Lots: Lot: 88528 Exp. 09/2021 - May 20, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Lots: Lot: 88530 Exp. 10/2021 - Feb 19, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for mechanical peel.
Lots: Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021. - Feb 19, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for mechanical peel.
Lots: Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021. - Feb 19, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for mechanical peel.
Lots: Lots #: 87580, Exp 4/2021, 87819, Exp 4/2021, 88244, Exp 6/2021, 88245, Exp 6/2021, 88532, Exp 06/2021 & 88533, Exp 7/2021. - Feb 19, 2021 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: Out of specification for mechanical peel.
Lots: Lots #: 87377, Exp 3/2021, 87572, Exp 3/2021, 87581, Exp 4/2021, 87820, Exp 5/2021, 88246, Exp 6/2021, 88535, Exp 7/2021, 88536, Exp 8/2021, 88537, Exp 8/2021 & 88939, Exp 8/2021. - Mar 31, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lot: 86647 Exp. 09/2020 - Mar 31, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lot: 86354 Exp. 08/2020 - Mar 31, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021 - Mar 2, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lot#: 86280, Exp 06/2020 - Mar 2, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020 - Mar 2, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lo#t: 86081, Exp 04/2020; 86196, Exp 06/2020 - Mar 2, 2020 · Class II · Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Lots: Lot#: 86083, Exp 05/2020; 86282, Exp 06/2020 - Apr 9, 2018 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for adhesive transfer.
Lots: Lot #: 82237 Exp. May 31, 2018 - Aug 30, 2017 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Lots: Lot: 80433 Exp. 08/17 - Aug 30, 2017 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Lots: Lot: 80431 Exp. 08/17 - Aug 30, 2017 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Lots: Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17 - Aug 30, 2017 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Lots: Lot: 80426 Exp. 10/17 - Aug 22, 2016 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Lots: Lot #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017. - Aug 22, 2016 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Lots: Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016 - Aug 22, 2016 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Lots: Lot #: 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016. - Dec 21, 2015 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot #: 77303, Exp 06/16 - Dec 21, 2015 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot # 77140, Exp 05/16 - Dec 21, 2015 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16 - Jul 27, 2015 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Lots: Lot #: 75983, Expiry: 11/15 - Jan 12, 2015 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: One lot exceeded the mechanical peel specification
Lots: Lot # 73346, Exp 03/2015 - Jul 15, 2014 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot # 71165; Exp. 12/14 - Feb 13, 2014 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Lots: Lot #69618, Exp. 09/14 - Feb 13, 2014 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Lots: Lot #70132, Exp. 09/14 - Jan 31, 2013 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Lots: Lot #59824, Exp 04/13 - Jul 12, 2012 · Class II · Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot # 55302, Exp 12/12 - Jul 12, 2012 · Class II · Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot # 56506, Exp 12/12 - Jul 12, 2012 · Class II · Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot #53823, Exp 08/12 - Mar 22, 2012 · Class II · Noven Pharmaceuticals, Inc.
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Lots: Lot # 53995 - Jul 5, 2011 · Class II · Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Lots: Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Methylphenidate: every company that makes it
- Form
- patch, transdermal
- Strength
- 30 mg per 9 h
- Approval
- NDA NDA021514
- On the market since
- Apr 6, 2006
- Package NDCs
68968-5555-3- Official label
- DailyMed (National Library of Medicine), updated Sep 1, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?