Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xarelto (rivaroxaban) Tablets 15 mg per tablet Recalled by Janssen Ortho L.L.C. Due to Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Janssen Ortho L.L.C. directly.
Affected Products
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Quantity: 13500 bottles
Why Was This Recalled?
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Janssen Ortho L.L.C.
Janssen Ortho L.L.C. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report