Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
0.9% Sodium Chloride Injection Recalled by Fresenius Medical Care Holdings, Inc. Due to Lack of Assurance of Sterility
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.
Affected Products
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Quantity: 3,651,468 containers
Why Was This Recalled?
Lack of Assurance of Sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report