US Drug Recall Register
Class III · Low risk Terminated Initiated Aug 4, 2017 (9 years ago)

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL…

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

Why it was recalled

Failed Dissolution Specifications

What was recalled

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.

Recalling firm
Pfizer Inc.
NDC code
24478-200-20
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1163-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Methylphenidate recalls

See all