FDA Drug recall D-0006-2015
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- FDA Drug
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 by Janssen Ortho, citing microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0006-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-17 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Janssen Ortho |
| Distribution | US |
Product
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Reason
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Identifiers
| code_info | Lot 13JG2616 Exp. 07/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0006-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.