Daytrana Patch
FDA Recall NDC 68968-5553
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 42 recorded enforcement report(s) associated with Daytrana (NDC 68968-5553). A significant event, classified as Class II, was initiated on Mar 10, 2023 by Noven Therapeutics, Llc. The reported reason for this action was: "Defective Delivery System: Out of specification for shear."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
D-0471-2023D-0473-2023D-0472-2023D-0470-2023D-0071-2023D-1169-2022D-0889-2022D-0393-2021D-0394-2021D-0293-2021D-0294-2021D-0296-2021D-0295-2021D-1248-2020D-1249-2020D-1247-2020D-1044-2020D-1045-2020D-1042-2020D-1043-2020D-0627-2018D-1169-2017D-1171-2017D-1172-2017D-1170-2017D-0429-2017D-0428-2017D-0430-2017D-1440-2016D-1439-2016D-1438-2016D-0008-2016D-1086-2015D-1608-2014D-1171-2014D-1172-2014D-312-2013D-1655-2012D-1654-2012D-1653-2012D-1413-2012D-1372-2012
Class II Ongoing
Defective Delivery System: Out of specification for shear.
Mar 10, 2023
Mar 29, 2023
N/A
Recall Profile & Regulatory Data
Event ID
91882
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
Batch or Lot Expiration Information
Lot# : 91956, Exp. 6/2023; 92475, Exp. 7/2023
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: Out of specification for shear.
Mar 10, 2023
Mar 29, 2023
N/A
Recall Profile & Regulatory Data
Event ID
91882
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: Out of specification for shear.
Mar 10, 2023
Mar 29, 2023
N/A
Recall Profile & Regulatory Data
Event ID
91882
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# : 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: Out of specification for shear.
Mar 10, 2023
Mar 29, 2023
N/A
Recall Profile & Regulatory Data
Event ID
91882
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.
Batch or Lot Expiration Information
Lot# : 91955, Exp. 7/2023; 93039, Exp. 10/2023
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
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.
Nov 16, 2022
Dec 07, 2022
3977 boxes
Recall Profile & Regulatory Data
Event ID
91161
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Batch or Lot Expiration Information
Lot# Lot: 91316 Exp. 02/2023
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Jun 24, 2022
Jul 06, 2022
8,559 cartons
Recall Profile & Regulatory Data
Event ID
90506
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3
Batch or Lot Expiration Information
Lot# Lot: 91272 Exp. 12/22.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: customer complaints exceeded respective action limits.
May 06, 2022
Jun 01, 2022
274, 110 patches
Recall Profile & Regulatory Data
Event ID
90162
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide to the U.S. Market
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
Batch or Lot Expiration Information
Lot# Lot: 90764 Exp. 08/2022
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Ongoing
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
May 20, 2021
Jun 02, 2021
9,587 boxes
Recall Profile & Regulatory Data
Event ID
87980
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Batch or Lot Expiration Information
Lot# Lot: 88528 Exp. 09/2021
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
68968-5552-1Product
Class II Ongoing
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
May 20, 2021
Jun 02, 2021
6,689 boxes
Recall Profile & Regulatory Data
Event ID
87980
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Batch or Lot Expiration Information
Lot# Lot: 88530 Exp. 10/2021
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
68968-5553-1Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel.
Feb 19, 2021
Mar 10, 2021
473,280 patches
Recall Profile & Regulatory Data
Event ID
87373
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 05, 2024
Product Description
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.
Batch or Lot Expiration Information
Lot# Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel.
Feb 19, 2021
Mar 10, 2021
551,670 patches
Recall Profile & Regulatory Data
Event ID
87373
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 05, 2024
Product Description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.
Batch or Lot Expiration Information
Lot# Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel.
Feb 19, 2021
Mar 10, 2021
934,140 patches
Recall Profile & Regulatory Data
Event ID
87373
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 05, 2024
Product Description
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel.
Feb 19, 2021
Mar 10, 2021
786,900 patches
Recall Profile & Regulatory Data
Event ID
87373
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 05, 2024
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 31, 2020
Apr 29, 2020
5,614 30-count boxes
Recall Profile & Regulatory Data
Event ID
85357
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jun 17, 2024
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Batch or Lot Expiration Information
Lot# Lot: 86354 Exp. 08/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 31, 2020
Apr 29, 2020
14,142 30-count boxes
Recall Profile & Regulatory Data
Event ID
85357
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jun 17, 2024
Product Description
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
Batch or Lot Expiration Information
Lot# Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 31, 2020
Apr 29, 2020
7957 30-count boxes
Recall Profile & Regulatory Data
Event ID
85357
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jun 17, 2024
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3
Batch or Lot Expiration Information
Lot# Lot: 86647 Exp. 09/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 02, 2020
Mar 25, 2020
11093 boxes
Recall Profile & Regulatory Data
Event ID
85128
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
May 18, 2023
Product Description
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3
Batch or Lot Expiration Information
Lot# Lo#t: 86081, Exp 04/2020; 86196, Exp 06/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 02, 2020
Mar 25, 2020
7469 boxes
Recall Profile & Regulatory Data
Event ID
85128
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
May 18, 2023
Product Description
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3
Batch or Lot Expiration Information
Lot# : 86083, Exp 05/2020; 86282, Exp 06/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 02, 2020
Mar 25, 2020
9513 boxes
Recall Profile & Regulatory Data
Event ID
85128
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
May 18, 2023
Product Description
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3
Batch or Lot Expiration Information
Lot# : 86280, Exp 06/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for mechanical peel and shear.
Mar 02, 2020
Mar 25, 2020
13761 boxes
Recall Profile & Regulatory Data
Event ID
85128
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Therapeutics, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
May 18, 2023
Product Description
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3
Batch or Lot Expiration Information
Lot# : 85942, Exp 03/2020; 86281, Exp 06/2020
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for adhesive transfer.
Apr 09, 2018
Apr 25, 2018
9016 boxes of 30 patch each
Recall Profile & Regulatory Data
Event ID
79781
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 24, 2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Batch or Lot Expiration Information
Lot# : 82237 Exp. May 31, 2018
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Aug 30, 2017
Sep 27, 2017
321,900 patches
Recall Profile & Regulatory Data
Event ID
78021
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 24, 2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3
Batch or Lot Expiration Information
Lot# Lot: 80433 Exp. 08/17
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Aug 30, 2017
Sep 27, 2017
331,950 patches
Recall Profile & Regulatory Data
Event ID
78021
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 24, 2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3
Batch or Lot Expiration Information
Lot# Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Aug 30, 2017
Sep 27, 2017
234,960 patches
Recall Profile & Regulatory Data
Event ID
78021
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 24, 2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3
Batch or Lot Expiration Information
Lot# Lot: 80426 Exp. 10/17
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Aug 30, 2017
Sep 27, 2017
182,850 patches
Recall Profile & Regulatory Data
Event ID
78021
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 24, 2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
Batch or Lot Expiration Information
Lot# Lot: 80431 Exp. 08/17
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Aug 22, 2016
Jan 18, 2017
364,830 patches
Recall Profile & Regulatory Data
Event ID
75450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Mar 20, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# : 79230, Exp. 02/2017; 77547, Exp.07/2016
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Aug 22, 2016
Jan 18, 2017
1,068,600 patches
Recall Profile & Regulatory Data
Event ID
75450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Mar 20, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
Batch or Lot Expiration Information
Lot# : 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Aug 22, 2016
Jan 18, 2017
357,420 patches
Recall Profile & Regulatory Data
Event ID
75450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Mar 20, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
Batch or Lot Expiration Information
Lot# : 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016.
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Dec 21, 2015
Jul 20, 2016
12285 boxes
Recall Profile & Regulatory Data
Event ID
73718
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
Batch or Lot Expiration Information
Lot# s: 77379, 77380, Exp 05/16; 76944, Exp 03/16
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Dec 21, 2015
Jul 20, 2016
2088 boxes
Recall Profile & Regulatory Data
Event ID
73718
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 77140, Exp 05/16
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Dec 21, 2015
Jul 20, 2016
7850 boxes
Recall Profile & Regulatory Data
Event ID
73718
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Batch or Lot Expiration Information
Lot# : 77303, Exp 06/16
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Jul 27, 2015
Oct 14, 2015
125,250 Patches
Recall Profile & Regulatory Data
Event ID
72174
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Mar 20, 2019
Product Description
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Batch or Lot Expiration Information
Lot# : 75983, Expiry: 11/15
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
Defective Delivery System: One lot exceeded the mechanical peel specification
Jan 12, 2015
Jun 03, 2015
125,340 Patches
Recall Profile & Regulatory Data
Event ID
71201
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
Batch or Lot Expiration Information
Lot# 73346, Exp 03/2015
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Jul 15, 2014
Oct 01, 2014
160,800 patches
Recall Profile & Regulatory Data
Event ID
69277
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 71165; Exp. 12/14
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Feb 13, 2014
Mar 26, 2014
187,860 patches
Recall Profile & Regulatory Data
Event ID
67718
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 69618, Exp. 09/14
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Feb 13, 2014
Mar 26, 2014
117,600 patches
Recall Profile & Regulatory Data
Event ID
67718
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 19, 2019
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.
Batch or Lot Expiration Information
Lot# 70132, Exp. 09/14
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Jan 31, 2013
May 08, 2013
335,910 patches
Recall Profile & Regulatory Data
Event ID
64710
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Dec 28, 2016
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Batch or Lot Expiration Information
Lot# 59824, Exp 04/13
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Jul 12, 2012
Aug 29, 2012
231,270 patches
Recall Profile & Regulatory Data
Event ID
62530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Aug 04, 2014
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Batch or Lot Expiration Information
Lot# 53823, Exp 08/12
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Jul 12, 2012
Aug 29, 2012
121,530 patches
Recall Profile & Regulatory Data
Event ID
62530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Aug 04, 2014
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3.
Batch or Lot Expiration Information
Lot# 56506, Exp 12/12
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
Class II Terminated
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.
Jul 12, 2012
Aug 29, 2012
177,900 patches
Recall Profile & Regulatory Data
Event ID
62530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Aug 04, 2014
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 55302, Exp 12/12
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
March 2012 Class II Recall: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Recall Number
Class II Terminated
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Mar 22, 2012
Jul 18, 2012
185,160 patches
Recall Profile & Regulatory Data
Event ID
62002
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 09, 2014
Product Description
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Batch or Lot Expiration Information
Lot# 53995
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
68968-5554-01Product
Class II Terminated
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.
Jul 05, 2011
Jun 20, 2012
357,510 patches
Recall Profile & Regulatory Data
Event ID
61891
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
May 23, 2013
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Batch or Lot Expiration Information
Lot# 's: a) 49203, Exp 10/12; b) 50265, Exp 01/13
Affected Packages Involved in this Recall
68968-5552-3Product
68968-5553-3Product
68968-5554-3Product
68968-5555-3Product
54092-554-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
