Xarelto (rivaroxaban recalls

The FDA has published 1 recall involving Xarelto (rivaroxaban since 2014. The latest was reported on 15 Oct 2014. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Oct 2014

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why xarelto (rivaroxaban is recalled

Sterility1100%

Companies

Janssen Ortho1100%

By year

20141100%

All xarelto (rivaroxaban recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2014Drug	CLASS II	Xarelto (rivaroxaban) Tablets recalled by Janssen Ortho	Janssen Ortho	Sterility	Nationwide

Should you stop taking Xarelto (rivaroxaban?

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.