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0.9% Sodium Chloride Injection, USP
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DRUG RECALLMODERATE

0.9% Sodium Chloride Injection, USP

Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL bags due to a lack of assurance of sterility.

What to do

Check your inventory for the affected product and contact your supplier or Fresenius Kabi for return instructions. Do not use the product if sterility is compromised.

Posted
Updated
Recall No.
D-0424-2026
Agency
Firm
Fresenius Kabi USA, LLC
Recall ID
98581
Status
ONGOING

Why it was recalled

Lack of Assurance of Sterility

How to identify it

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).

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification