Risperidone recalls

The FDA has published 5 recalls involving Risperidone since 2014. The latest was reported on 2 Jun 2021. Most were for sterility. Torrent Pharma has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Jun 2021

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why risperidone is recalled

Companies

By year

2021120%
2019240%
2014240%

All risperidone recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021Drug	CLASS II	Risperidone 1mg/ML recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
19 Jun 2019Drug	CLASS II	RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
19 Jun 2019Drug	CLASS II	RisperiDONE Oral Solution, USP, 1 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
13 Aug 2014Drug	CLASS II	Risperdal Consta (risperiDONE), 25 mg Dose Pack recalledRisperdal Consta	Janssen Pharmaceuticals	Sterility	Nationwide
7 May 2014Drug	CLASS III	Risperidone Oral Solution, 1 mg/mL recalled by Apotex	Apotex	Potency & Assay	Nationwide

Should you stop taking Risperidone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.