Fresenius Medical Care 0.9% Sodium Chloride Injection Recall: Lack of Sterility Assurance
Fresenius Medical Care recalls 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected units have specific NDC codes and expiration dates. Consumers should stop using and contact the company for details.
Stop using this now
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Fresenius Medical Care is recalling certain 0.9% Sodium Chloride Injection products because they may not be sterile. This could lead to infections if used improperly. Affected products have specific NDC codes and expiration dates listed in the recall. Read more at govinfonow.com/recall/32051-fresenius-medical-care-0-9-sodium-chloride-injection-recall-lack.
Source Summary by GovInfoNow · govinfonow.com/recall/32051-fresenius-medical-care-0-9-sodium-chloride-injection-recall-lack · Updated August 17, 2026 · FDA enforcement record: FDA #D-0490-2025
Cite this page
“Fresenius Medical Care 0.9% Sodium Chloride Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32051-fresenius-medical-care-0-9-sodium-chloride-injection-recall-lack. Based on FDA recall #D-0490-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2025%22&limit=1).
Why it’s dangerous
The injection products lack assurance of sterility, meaning they could be contaminated with bacteria or other pathogens. If used, this could lead to infections, especially in medical settings where sterile conditions are critical.
Who’s affected
Healthcare professionals and patients who have the recalled 0.9% Sodium Chloride Injection products with the listed NDC codes and expiration dates are affected. Those using the product for medical purposes are at the highest risk.
How to tell if you have this one
Check the product's NDC code on the container. The affected products have specific NDC codes listed in the recall, such as 24PU06037, 24SU06001, and others, with expiration dates up to 03/31/2026.
- Brand
Fresenius Medical Care- Category
Drug
What to do — step by step
Stop Using Immediately
Discard any affected products as they may not be sterile and could cause infections.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0490-2025 (May 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0490-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.