Fresenius Kabi Usa, Llc: 0.9% Sodium Chloride Injection, Usp 900 Mg Per
Recall Summary Fresenius Kabi USA is recalling 0.9% Sodium Chloride Injection (a sterile salt solution) in 1,000 mL bags distributed nationwide because the company cannot guarantee the product is sterile. This is a Class II recall, meaning the product could cause serious health problems if used. The affected product was manufactured by Fresenius Kabi, distributed by BD, and was sold across all U.S. states, Puerto Rico, and Alaska.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-11
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2aa45eb1-b29e-406a-bdda-c77118b9cd8a