thejoe Noven Pharmaceuticals, Inc.

Noven Pharmaceuticals, Inc.: 51 FDA recall reports

Every drug recall the FDA has published for Noven Pharmaceuticals, Inc.. The fault, and how the agency graded it.

51Reports

0Class I

12Ongoing

2024-11-27Most 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	50
Class III	1

By year reported

Year	Reports
2012	8
2013	1
2014	3
2015	3
2016	3
2017	8
2018	7
2021	10
2022	3
2023	4
2024	1

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.

Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed tra

D-0055-2025 · Class II · reported 2024-11-27 · Ongoing

Why it was recalled: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Product: Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
Where it went: USA nationwide.
How much: 685 boxes

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

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx

D-0724-2021 · Class II · reported 2021-08-25 · Ongoing

Why it was recalled: Failed Stability Specifications; out of specification for shear.
Product: Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Where it went: Nationwide.
How much: 223,382 boxes

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx On

D-0725-2021 · Class II · reported 2021-08-25 · Ongoing

Why it was recalled: Failed Stability Specifications; out of specification for shear.
Product: Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Where it went: Nationwide.
How much: 70,638 boxes

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

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, I

D-0337-2021 · Class II · reported 2021-04-28 · Terminated

Why it was recalled: 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.
Product: Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
Where it went: Nationwide within the United States
How much: 10872 cartons

Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmac

D-0336-2021 · Class II · reported 2021-04-28 · Terminated

Why it was recalled: 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.
Product: Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Where it went: Nationwide within the United States
How much: 12060 cartons

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

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Nove

D-1209-2018 · Class II · reported 2018-10-03 · Terminated

Why it was recalled: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
Where it went: Nationwide
How much: 26217 boxes of 8 patches

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only

D-1207-2018 · Class II · reported 2018-10-03 · Terminated

Why it was recalled: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product: Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
Where it went: Nationwide
How much: 213714 boxes of 8 patches and 15927 boxes of 2 patches

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Nove

D-1210-2018 · Class II · reported 2018-10-03 · Terminated

Why it was recalled: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
Where it went: Nationwide
How much: 74908 boxes of 8 patches

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only,

D-1208-2018 · Class II · reported 2018-10-03 · Terminated

Why it was recalled: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product: Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
Where it went: Nationwide
How much: 149631 boxes of 8 patches and 15809 boxes of 2 patches

Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouc

D-0862-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: 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.
Product: Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Where it went: Nationwide in the USA.
How much: 61960 boxes

Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 p

D-0863-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: 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.
Product: Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Where it went: Nationwide in the USA.
How much: 70870 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

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Nove

D-0923-2017 · Class III · reported 2017-07-05 · Terminated

Why it was recalled: Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Product: Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Where it went: Nationwide within US
How much: 14434 cartons

Showing the 30 most recent of 51. 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.

← All drug recalls