Janssen Recalls Xarelto Tablets Due to Microbial Contamination
Janssen Ortho L.L.C. is recalling 13,500 bottles of Xarelto (rivaroxaban) 15 mg tablets due to confirmed microbial contamination in a sales sample.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves confirmed microbial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health consequences).
Plain-English summary
Janssen Ortho L.L.C. is recalling 13,500 bottles of Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only. The product is identified by NDC 50458-578-99, Lot 13JG2616, and an expiration date of 07/16. The bottles were manufactured by JOLLC in Gurabo, Puerto Rico, and distributed nationwide.
The recall was initiated after a consumer complaint confirmed microbial contamination in a sales sample of the non-sterile product. The agency has classified this recall as Class II.
Consumers who possess the affected product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- Manufacturer
- Janssen Ortho L.L.C.
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 13,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 13JG2616 Exp. 07/16
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Janssen Ortho L.L.C.
See all →- LowInvokamet Recalled for Incorrect or Missing Package Insert Labeling
FDA (Drugs) · 2016-11-02
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighMylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
FDA (Drugs) · 2017-04-05
- LowInvokamet Recalled for Incorrect or Missing Package Insert Labeling
FDA (Drugs) · 2016-11-02
- ModerateJanssen Recalls Ortho-Novum 1/35 Due to Incorrect Dispenser Instructions
FDA (Drugs) · 2018-11-14
- SevereRuzurgi (amifampridine) Tablets Recalled for Microbial Contamination
FDA (Drugs) · 2021-10-06
- ModerateSandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
FDA (Drugs) · 2016-02-17
- SevereWarner Chilcott Recalls Enablex Extended Release Tablets Due to Impurities
FDA (Drugs) · 2013-08-07