Is Methylphenidate recalled?

68 FDA recalls mention Methylphenidate. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Methylphenidate.

Class II · Moderate risk Terminated Jan 27, 2020

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA…

Reason CGMP deviations: Product bottle may be absent of desiccant.

Teva Pharmaceuticals USA NDC 62037-725-01 D-0836-2020

Class III · Low risk Terminated Oct 4, 2019

Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc…

Reason Presence of Foreign Substance; Fiber particles.

KVK-Tech, Inc. NDC 10702-0163-50 D-0142-2020

Class III · Low risk Terminated Apr 17, 2018

Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals…

Reason Failed Dissolution Specification: Low dissolution outside of specifications

Rhodes Pharmaceuticals, L.P. NDC 42858-402-45 D-0710-2018

Class II · Moderate risk Terminated Apr 9, 2018

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

Reason Defective Delivery System: Out of specification for adhesive transfer.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-0627-2018

Class III · Low risk Terminated Feb 28, 2018

Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC…

Reason Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

Osmotica Pharmaceutical Corp NDC 13811-708-10 D-0581-2018

Class III · Low risk Terminated Dec 18, 2017

Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC…

Reason Subpotent Drug

Osmotica Pharmaceutical Corp NDC 13811-709-10 D-0111-2018

Class III · Low risk Terminated Dec 18, 2017

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC…

Reason Subpotent Drug

Osmotica Pharmaceutical Corp NDC 13811-707-10 D-0110-2018

Class III · Low risk Terminated Oct 17, 2017

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona…

Reason Failed Dissolution Specifications: Low out of specification results for dissolution.

Teva Pharmaceuticals USA NDC 0591-5884-01 D-0052-2018

Class II · Moderate risk Terminated Aug 30, 2017

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

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1172-2017

Class II · Moderate risk Terminated Aug 30, 2017

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

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1171-2017

Class II · Moderate risk Terminated Aug 30, 2017

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

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1170-2017

Class II · Moderate risk Terminated Aug 30, 2017

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

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-1169-2017

Class III · Low risk Terminated Aug 4, 2017

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL…

Reason Failed Dissolution Specifications

Pfizer Inc. NDC 24478-200-25 D-1164-2017

Class III · Low risk Terminated Aug 4, 2017

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL…

Reason Failed Dissolution Specifications

Pfizer Inc. NDC 24478-200-20 D-1163-2017

Class III · Low risk Terminated Mar 7, 2017

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by…

Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Pfizer Inc NDC 24478-190-30 D-0609-2017

Class III · Low risk Terminated Mar 7, 2017

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by…

Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Pfizer Inc NDC 24478-205-25 D-0608-2017

Class III · Low risk Terminated Mar 7, 2017

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by…

Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Pfizer Inc NDC 24478-190-10 D-0607-2017

Class II · Moderate risk Terminated Aug 22, 2016

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-0430-2017

Class II · Moderate risk Terminated Aug 22, 2016

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-0429-2017

Class II · Moderate risk Terminated Aug 22, 2016

Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-0428-2017

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1440-2016

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1439-2016

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1438-2016

Class III · Low risk Terminated Jul 28, 2015

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC…

Reason Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution…

Novartis Pharmaceuticals Corp. D-1430-2015

Class II · Moderate risk Terminated Jul 27, 2015

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for…

Reason Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Noven Pharmaceuticals, Inc. D-0008-2016

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