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, 750mg/150 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, 750mg/150 mL total volume (When constituted with 131 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 24478-200-25.

Recalling firm
Pfizer Inc.
NDC code
24478-200-25
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1164-2017

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.

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