Thiamine HCl recalled over sterility concerns

Recall date

February 5, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fresenius Kabi Compounding, LLC recalls thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road…

Recall number

D-0335-2026

FDA classification

Class II

Brand / firm

Fresenius Kabi Compounding, LLC

Sold / distributed

US Nationwide.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.