Fresenius Kabi: Multiple Sale NDC Number Injections
Fresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
Stop using the recalled products immediately. Check your inventory for the affected NDC numbers and lot codes listed in the recall notice. Contact Fresenius Kabi for instructions on returning the products and obtaining a replacement or credit.
Why it was recalled
Fresenius Kabi is recalling multiple lots of 0.9% Sodium Chloride Injection, USP, and 0.45% Sodium Chloride Injection, USP, due to a lack of assurance of sterility. The recall includes 14 distinct products in various container sizes, including 50 mL, 100 mL, 250 mL, 500 mL, and 1,000 mL bags, as well as 5% Dextrose Injection. Consumers and healthcare providers should check their inventory for affected lots and discontinue use immediately.
Is mine affected?
This recall covers 14 products. Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL ( | 4.5 mg | NDC 63323-626-03 | D-0424-2026 |
| 0.9% Sodium Chloride Injection, USP | 900 mg | NDC 65219-432-20 | D-0432-2026 |
| 0.9% Sodium Chloride Injection, USP, 0.9% ( | 900 mg | NDC 65219-468-05 | D-0426-2026 |
| 0.9% Sodium Chloride Injection, USP, (2 | 250 mg | NDC 65219-470-05 | D-0427-2026 |
| 0.9% Sodium Chloride Injection, USP 0.9% ( | 450 mg | NDC 65219-466-05 | D-0425-2026 |
| 0.9% Sodium Chloride Injection, USP, (4 | 500 mg | NDC 65219-472-05 | D-0428-2026 |
| 5% Dextrose Injection, USP 5 g per 100 mL ( | 50 mg | NDC 65219-464-05 | D-0436-2026 |
| 5% Dextrose Injection, USP 12.5 g per 250 mL ( | 50 mg | NDC 65219-458-05 | D-0437-2026 |
Show all 14 products
| Product | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| 0.9% Sodium Chloride Injection, USP | 900 mg | NDC 65219-282-01 | D-0433-2026 |
| 5% Dextrose Injection, USP 2.5 g per 50 mL ( | 50 mg | NDC 65219-456-05 | D-0435-2026 |
| 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, 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: 17271-701-02. | – | – | D-0429-2026 |
| 0.9% Sodium Chloride Injection, USP | 900 mg | – | D-0430-2026 |
| 0.9% Sodium Chloride Injection, USP | 900 mg | – | D-0434-2026 |
| 0.9% Sodium Chloride Injection, USP | 900 mg | – | D-0431-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Fresenius Kabi USA, LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification