US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 17, 2014 (12 years ago)

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

What was recalled

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99

Recalling firm
Janssen Ortho L.L.C.
NDC code
50458-578-99
Origin
PR, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0006-2015

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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