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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 6004…

Lack of Assurance of Sterility

Class II Medicine & devices FDA April 15, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Fresenius Kabi USA, LLC — Lake Zurich, IL
Severity
Class II — moderate
Reported
April 15, 2026
Recall number
D-0428-2026
Status
Ongoing
Source
FDA

Where it went

US Nationwide , Alaska, and Puerto Rico.

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