Moderate riskFDA DrugApr 15, 2026Class II

Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline) in 100 mL bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls

What to do

Check the batch number and expiration date on your saline bags against the recalled batches (6402299, 6402300, 6402301, 6402302, 6402303, 6402305, 6402398, 6402467, 6402577, 6402578).
Do not use affected bags. Contact your healthcare facility or pharmacy for instructions on safe disposal and replacement.
If you or someone in your care received this product, inform your healthcare provider.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 14 products — see all of them.

Details

Illnesses reported: None reported
Manufactured in: 3 Corporate Dr, Lake Zurich, IL, United States
Classification: Class II
Recall number: D-0426-2026

In the FDA's words

Description: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. Lack of Assurance of Sterility Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027. Distribution: US Nationwide , Alaska, and Puerto Rico.
Hazard: Lack of Assurance of Sterility

14 products in this recall

Fresenius Kabi IV saline and dextrose bags recalled over sterility

Fresenius Kabi is recalling 14 sodium chloride and dextrose IV fluid bags because the company cannot assure they are sterile. The products were sold under the Fresenius Kabi, BD and Fresenius Medical Care names and were distributed nationwide, to Alaska and to Puerto Rico. No injuries have been reported.

The agency lists each product separately. Check every one you might have.