5% Dextrose Injection recalled over sterility concerns

Recall date

March 11, 2026

Source

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

Official notice title

Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("…

Recall number

D-0437-2026

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

US Nationwide , Alaska, and Puerto Rico.

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

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.