Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Rivaroxaban recalled?

Not under an active recall. Rivaroxaban was recalled 3 times in the past — all now closed. Most recent: Nov 14, 2014.

Most common reason: Cross-contamination (1 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Rivaroxaban. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Rivaroxaban recalls on record

none so far in 2026; 3 on record, newest first
Class II · Moderate risk

Rivaroxaban active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-882-2015
Class II · Moderate risk

Xarelto (rivaroxaban)

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

Terminated Microbial contamination Janssen Ortho L.L.C. NDC 50458-578-99 D-0006-2015
Class II · Moderate risk

RIVAROXABAN Tablet

Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: W002619, EXP: 6/4/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-596-2014