Fresenius Kabi Compounding, Llc: Thiamine Hcl, 500 Mg, 500 Mg Added To

Recall Summary Fresenius Kabi Compounding is recalling thiamine HCl 500 mg injections (a B-vitamin medication) distributed nationwide because the sterility of the product cannot be assured—meaning it may not be safe from contamination. This is a Class I recall, the most serious type. The affected product is thiamine HCl 500 mg added to 100 mL of 0.9% Sodium Chloride Injection with NDC number 71506-079-56, made by Fagron Sterile Services in Canton, Massachusetts.

Recalling firm

Fresenius Kabi Compounding, LLC

Product

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, NDC 71506-079-56.

Reason

Lack of Assurance of Sterility

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-02-05

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

US Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/f876ec38-6866-48ee-a546-9afa34a6f1ed