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High risk Drugs & MedicationsClass II

Fresenius Kabi Thiamine HCl Injection Recall

Thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, N

Updated February 5, 2026

Fresenius Kabi's thiamine HCl injection cannot be guaranteed to be sterile, which could allow bacteria or other contaminants into the bloodstream. Healthcare providers should immediately verify the integrity of any units before use.

Is the Fresenius Kabi Compounding, LLC recalled? Yes. This product was recalled by FDA on February 5, 2026. Details below.

What is recalled

Thiamine HCl, 500 mg added to 100 mL of 0.9% Sodium Chloride Injection, USP, manufactured by Fagron Sterile Services. NDC number: 71506-079-56. Product supplied by Fresenius Kabi Compounding, LLC.

Am I affected

You are affected if you are a healthcare provider or facility that has received this thiamine HCl injection product with NDC 71506-079-56 from Fresenius Kabi. Check your inventory for this specific NDC number on the vial or bag label.

What to do right now

Stop using this product immediately. Do not administer to patients. Contact your supplier or Fresenius Kabi Compounding, LLC to report the product and arrange return or quarantine of all affected units.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi Compounding, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0335-2026
Classification
Class II
Recalled
February 5, 2026
Read the official notice

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