Class IIOngoing

0.9% Sodium Chloride Injection recall

FDA recall D-0433-2026 · initiated Mar 11, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

Product: 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.
Recalling company: Fresenius Kabi USA LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide , Alaska, and Puerto Rico.
Initiated: Mar 11, 2026
FDA report date: Apr 15, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0433-2026 ↗

← All drug recalls