thejoe Methylphenidate

Methylphenidate recalls: 42 FDA reports

Recalls involving Methylphenidate. What was wrong with each batch, and how the FDA graded the risk.

42Reports

0Class I

9Ongoing

2023-03-29Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	42

By year reported

Year	Reports
2012	5
2013	1
2014	3
2015	2
2016	3
2017	7
2018	1
2020	7
2021	6
2022	3
2023	4

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven The

D-0473-2023 · Class II · reported 2023-03-29 · Ongoing

Why it was recalled: Defective Delivery System: Out of specification for shear.
Product: 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
Where it went: US Nationwide
How much: N/A

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Ther

D-0470-2023 · Class II · reported 2023-03-29 · Ongoing

Why it was recalled: Defective Delivery System: Out of specification for shear.
Product: 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.
Where it went: US Nationwide
How much: N/A

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven The

D-0471-2023 · Class II · reported 2023-03-29 · Ongoing

Why it was recalled: Defective Delivery System: Out of specification for shear.
Product: 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
Where it went: US Nationwide
How much: N/A

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Ther

D-0472-2023 · Class II · reported 2023-03-29 · Ongoing

Why it was recalled: Defective Delivery System: Out of specification for shear.
Product: 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.
Where it went: US Nationwide
How much: N/A

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, R

D-0071-2023 · Class II · reported 2022-12-07 · Ongoing

Why it was recalled: 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.
Product: 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.
Where it went: Nationwide in the USA
How much: 3977 boxes

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx

D-1169-2022 · Class II · reported 2022-07-06 · Ongoing

Why it was recalled: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Product: 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
Where it went: Distributed Nationwide in the USA
How much: 8,559 cartons

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx

D-0889-2022 · Class II · reported 2022-06-01 · Ongoing

Why it was recalled: Defective Delivery System: customer complaints exceeded respective action limits.
Product: 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
Where it went: Nationwide to the U.S. Market
How much: 274, 110 patches

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-

D-0393-2021 · Class II · reported 2021-06-02 · Ongoing

Why it was recalled: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Product: 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.
Where it went: Nationwide in the USA
How much: 9,587 boxes

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-

D-0394-2021 · Class II · reported 2021-06-02 · Ongoing

Why it was recalled: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Product: 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.
Where it went: Nationwide in the USA
How much: 6,689 boxes

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in

D-0296-2021 · Class II · reported 2021-03-10 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel.
Product: 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.
Where it went: Nationwide in the USA
How much: 934,140 patches

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches i

D-0294-2021 · Class II · reported 2021-03-10 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel.
Product: 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.
Where it went: Nationwide in the USA
How much: 551,670 patches

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches i

D-0293-2021 · Class II · reported 2021-03-10 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel.
Product: 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.
Where it went: Nationwide in the USA
How much: 473,280 patches

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in

D-0295-2021 · Class II · reported 2021-03-10 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel.
Product: 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.
Where it went: Nationwide in the USA
How much: 786,900 patches

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only,

D-1247-2020 · Class II · reported 2020-04-29 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: Distributed Nationwide in the US
How much: 7957 30-count boxes

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, M

D-1248-2020 · Class II · reported 2020-04-29 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: Distributed Nationwide in the US
How much: 5,614 30-count boxes

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, M

D-1249-2020 · Class II · reported 2020-04-29 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: Distributed Nationwide in the US
How much: 14,142 30-count boxes

Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box,

D-1044-2020 · Class II · reported 2020-03-25 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: U.S.A. Nationwide
How much: 11093 boxes

Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box,

D-1045-2020 · Class II · reported 2020-03-25 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: U.S.A. Nationwide
How much: 7469 boxes

Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box,

D-1042-2020 · Class II · reported 2020-03-25 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: U.S.A. Nationwide
How much: 9513 boxes

Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box,

D-1043-2020 · Class II · reported 2020-03-25 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for mechanical peel and shear.
Product: 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
Where it went: U.S.A. Nationwide
How much: 13761 boxes

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx

D-0627-2018 · Class II · reported 2018-04-25 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for adhesive transfer.
Product: 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
Where it went: Nationwide.
How much: 9016 boxes of 30 patch each

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Pat

D-1171-2017 · Class II · reported 2017-09-27 · Terminated

Why it was recalled: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Product: 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
Where it went: Nationwide.
How much: 331,950 patches

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Pat

D-1170-2017 · Class II · reported 2017-09-27 · Terminated

Why it was recalled: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Product: 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
Where it went: Nationwide.
How much: 182,850 patches

Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Pat

D-1172-2017 · Class II · reported 2017-09-27 · Terminated

Why it was recalled: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Product: 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
Where it went: Nationwide.
How much: 234,960 patches

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Pat

D-1169-2017 · Class II · reported 2017-09-27 · Terminated

Why it was recalled: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Product: 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
Where it went: Nationwide.
How much: 321,900 patches

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 3

D-0429-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Product: 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.
Where it went: Nationwide within the US
How much: 364,830 patches

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 3

D-0430-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Product: 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.
Where it went: Nationwide within the US
How much: 357,420 patches

Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 3

D-0428-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Product: 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
Where it went: Nationwide within the US
How much: 1,068,600 patches

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 3

D-1439-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
Product: 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.
Where it went: Nationwide
How much: 2088 boxes

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 3

D-1438-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: 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.
Product: 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.
Where it went: Nationwide
How much: 7850 boxes

Showing the 30 most recent of 42. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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