Vancomycin HCI recalled over sterility concerns

Recall date

March 20, 2026

Source

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

Official notice title

Fagron Compounding Services recalls Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N…

Recall number

D-0441-2026

FDA classification

Class II

Brand / firm

Fagron Compounding Services

Sold / distributed

Nationwide in the U.S.A.

Why it was recalled

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

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

What was recalled

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01