Recall: D-0424-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-11Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

Product

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Reason

Lack of Assurance of Sterility

Distribution

US Nationwide , Alaska, and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.