5% Dextrose Injection, Usp 2.5 G Per 50 Ml (50 Mg Per Ml) 50 Ml In A 100 Ml Freeflex Bag, Fresenius Kabi Usa, LLC ("fresenius Kabi"), Unit Of Use Ndc: 65219-456-05, Unit Of Sale Ndc Number: 65219-456-
Recall Summary Fresenius Kabi is recalling 5% Dextrose Injection in 50 mL FreeFlex bags distributed nationwide because the company cannot guarantee the product is sterile. This Class II recall affects the injectable drug with NDC numbers 65219-456-05 and 65219-456-60.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
- 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/d8f18741-6ab8-44be-8a9c-d918b973f4ac