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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: March 29, 2021
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Summary

Cardinal Health Inc. is recalling 48 boxes of Tremfya (guselkumab) Injection, 100 mg/mL, because the medication may have been exposed to improper temperatures during storage or distribution. Tremfya is a prescription injection used to treat certain inflammatory conditions, and maintaining the correct temperature is critical for the drug's safety and effectiveness. These products were distributed in Alabama, Louisiana, Mississippi, and Tennessee. If you have this medication, you should contact your healthcare provider or pharmacist immediately to determine if your specific supply is safe to use.

Risk

Exposure to temperatures outside of the manufacturer's required range, known as temperature abuse, can cause the medication to break down or lose its effectiveness. This may result in the patient receiving a less potent dose than intended, which could lead to inadequate treatment of their medical condition.

What You Should Do

  1. Check your medication carton for the product name Tremfya (guselkumab) Injection, 100 mg/mL, in a single-dose prefilled syringe.
  2. Identify the affected product by looking for code KESOY.AI with an expiration date of 04/2022 and NDC 57894-640-01.
  3. Contact your healthcare provider or pharmacist immediately to discuss whether your medication was part of this recall and to receive guidance on its safety.
  4. Return any unused, affected product to the pharmacy where you purchased it for a refund.
  5. Contact Cardinal Health Inc. at their Dublin, Ohio headquarters if you have further questions regarding the return process.
  6. For general consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton
Model:
NDC 57894-640-01
Lot Numbers:
KESOY.AI (Exp. 04/2022)
Date Ranges: Expiration 04/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87489
Status: Resolved
Manufacturer: Cardinal Health Inc.
Sold By: Pharmacies; Healthcare providers
Manufactured In: United States
Units Affected: 48 boxes
Distributed To: Alabama, Louisiana, Mississippi, Tennessee

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.