Xarelto — Class II drug recall D-0006-2015
Terminated recall by Janssen Ortho L.L.C., reported 2014-10-15, distributed nationwide. Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales
| Recall number | D-0006-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Janssen Ortho L.L.C., Gurabo, PR, United States |
| Recall initiated | 2014-09-17 |
| Classified | 2014-10-03 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 13,500 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 50458-0578-99 |
| Lot numbers | 07/16, 13JG2616 |
Product
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Reason for recall
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0006-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.