CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
Xarelto (rivaroxaban) Tablets recalled by Janssen Ortho
Janssen Ortho is recalling Xarelto (rivaroxaban) Tablets, distributed nationwide in the US. The recall was initiated on 17 Sep 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0006-2015
- FDA event ID
- 69302
- Recalling firm
- Janssen Ortho, Gurabo, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2014
- FDA classified
- 3 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 17 Sep 2014 | Recall initiated by company | |
| 3 Oct 2014 | Classified by FDA | +16 days |
| 15 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Which lots are affected?
Lot 13JG2616 Exp. 07/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Janssen Ortho
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg recalledInvokamet | Janssen Ortho | Packaging Defects | Nationwide |