Cardinal Health Inc. recalls Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by:
Cardinal Health recalls Tremfya (guselkumab) injections due to temperature abuse risks. This product may be unsafe if exposed to high temperatures.
Lower-risk recall
Temperature Abuse
Contact the company & request your remedy
What happened, in plain English
Cardinal Health is recalling Tremfya (guselkumab) injections because they can be damaged by high temperatures. This could lead to unsafe use if the product is not stored properly. Read more at govinfonow.com/recall/36491-tremf-temperature-abuse-recall-cardiac-health.
Source Summary by GovInfoNow · govinfonow.com/recall/36491-tremf-temperature-abuse-recall-cardiac-health · Updated October 4, 2026 · FDA enforcement record: FDA #D-0314-2021
Cite this page
“Tremf: Temperature Abuse Recall - Cardiac Health.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36491-tremf-temperature-abuse-recall-cardiac-health. Based on FDA recall #D-0314-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0314-2021%22&limit=1).
Why it’s dangerous
The product can be affected by high temperatures, which may cause the injection to become unsafe. This is a temperature abuse risk, meaning the product could be compromised if stored in warm conditions.
Who’s affected
People with prescriptions for Tremfya injections who received this specific product from Cardinal Health. Those storing the product in hot environments are at higher risk.
How to tell if you have this one
Check for the product name 'Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only'. The NDC code 57894-640-01 is also a key identifier.
- Brand
Cardinal Health- Category
Drug
What to do — step by step
Check Storage Conditions
Ensure the product is stored in a cool, dry place away from direct sunlight and heat sources.
Questions people ask
Is this product safe to use?
The product may be unsafe if exposed to high temperatures, so it's important to check storage conditions.
How can I tell if I have the recalled product?
Look for the product name 'Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only' and the NDC code 57894-640-01.
What should I do if I have the recalled product?
Ensure it's stored in a cool, dry place away from direct sunlight and heat sources. No immediate action is required if stored properly.
Contact Cardinal Health
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall D-0314-2021 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall D-0314-2021 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0314-2021 (March 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0314-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.