Class III · Low risk Ongoing
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
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
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen…
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New…
Reason Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only…
Reason Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of…
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured…
Reason Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured…
Reason Defective Delivery System: customer complaints exceeded respective action limits.
Class II · Moderate risk Ongoing
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc…
Reason Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that…
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box…
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box…
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed…
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed…
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed…
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed…
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only…
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA…
Reason CGMP deviations: Product bottle may be absent of desiccant.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.