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, Rx only, B…

Recall number

D-0434-2026

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, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.