Drugplain

risperidone

risperidone · KIT · Lupin Pharmaceuticals, Inc.

6 Recalls on Record
Plain English

risperidone is a kit containing risperidone. Manufactured by Lupin Pharmaceuticals, Inc..

Key Facts

Brand Name
risperidone
Generic Name
risperidone
NDC Code (Product)
70748-272
Manufacturer
Lupin Pharmaceuticals, Inc.
Dosage Form
KIT
Marketing Status
Application #
ANDA211220
Marketing Start
10/17/2025

Recall History

6 Recalls on Record
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II09/11/2013

Janssen Pharmaceuticals, Inc.

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

TerminatedVoluntary: Firm initiated
Class III01/14/2016

Zydus Pharmaceuticals USA Inc

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class III03/20/2014

Apotex Inc.

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is risperidone used for?

risperidone contains risperidone. It is a kit taken as directed. Consult your doctor for specific uses.

Is risperidone a controlled substance?

risperidone is not classified as a controlled substance by the DEA.

What is the generic name for risperidone?

The generic name for risperidone is risperidone. There are 11 other brand versions of risperidone.

What is the NDC code for risperidone ?

The NDC (National Drug Code) for risperidone is 70748-272, listed by Lupin Pharmaceuticals, Inc..

Product NDC

70748-272

Package NDC

70748-272-13

Other risperidone Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)