Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tremfya (guselkumab) Injection Recalled by Cardinal Health Inc. Due to Temperature Abuse

Date: March 9, 2021
Company: Cardinal Health Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health Inc. directly.

Affected Products

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.

Quantity: 48 boxes

Why Was This Recalled?

Temperature Abuse

Where Was This Sold?

This product was distributed to 4 states: AL, LA, MS, TN

Affected (4 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report