The Recall Registry
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Home Prescription medicine Fresenius Kabi USA, LLC — 0.45% Sodium Chloride…

Food & drug recall · FDAMarch 11, 2026Serious

Fresenius Kabi USA, LLC — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Lack of Assurance of Sterility

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Fresenius Kabi USA, LLC

The 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).

Details

Recall date
March 11, 2026
Brand
Fresenius Kabi USA, LLC
Model, lot or SKU numbers
Batch # 6402413, Exp Date: 02/29/2028
Where it was distributed

US Nationwide , Alaska, and Puerto Rico

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Fresenius Kabi USA, LLC — 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-

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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