Fresenius Kabi USA product 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 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx1…

Recall number

D-0433-2026

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

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.