Fresenius Kabi USA, LLC 2026-04-15 Health serious FDA
Health · FDA · Recall #FDA-D-0428-2026
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500… Recall
Issued April 15, 2026 · Fresenius Kabi USA, LLC
In April 2026, Fresenius Kabi USA, LLC recalled the 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility
What you should do
- 1 Stop using 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi USA, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- April 15, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide , Alaska, and Puerto Rico.
- Recall number
- FDA-D-0428-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi USA, LLC has 16 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.