FDA · Drugs ·
0.9% Sodium Chloride Injection recall
Fresenius Kabi USA, LLC recalled 0.9% Sodium Chloride Injection on April 15, 2026 because of lack of Assurance of Sterility. It was sold nationwide.
Why it was recalled
Lack of Assurance of Sterility
What's recalled
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide , Alaska, and Puerto Rico. - Status
- Ongoing
- Recall number
- D-0430-2026
- Source
- U.S. Food and Drug Administration
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