The Recall Desk
SevereFDA (Drugs)·D-0006-2015·Announced 2014-10-15

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

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