Warning
Fresenius Kabi USA Recalls 0.9% Sodium Chloride Injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0428-2026Drug / Pharmaceutical
Fresenius Kabi USA Recalls 0.9% Sodium Chloride Injection
Fresenius Kabi USA, LLC · Class II — Moderate Risk
Product Description
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide , Alaska, and Puerto Rico.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Fresenius Kabi USA, LLC has recalled a pharmaceutical product that the FDA classified as Class II. The recall was initiated on March 11, 2026. Lack of Assurance of Sterility. It was distributed in US Nationwide, Alaska, and Puerto Rico. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects and Fresenius Kabi USA recalls.