Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Pfizer Inc

NDC code

24478-205-25

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0608-2017

Other Methylphenidate recalls

See all

Class III · Low risk Ongoing Jun 1, 2026

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

Sandoz Inc D-0608-2026

Class II · Moderate risk Terminated Jun 17, 2024

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.

Trigen Laboratories NDC 13811-708-10 D-0579-2024

Class II · Moderate risk Terminated Jul 13, 2023

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.

Sun Pharmaceutical Industries INC NDC 57664-230-88 D-0940-2023

Class II · Moderate risk Ongoing Mar 10, 2023

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.

Noven Pharmaceuticals Inc NDC 68968-5555-3 D-0473-2023

Class II · Moderate risk Ongoing Mar 10, 2023

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.

Noven Pharmaceuticals Inc NDC 68968-5554-3 D-0472-2023