Recall of Fresenius Kabi Sodium Chloride Injection
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Fresenius Kabi USA, LLC is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility, affecting products distributed nationwide in the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
What Happened
Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection, USP, because of a lack of assurance of sterility. This voluntary recall was initiated on March 11, 2026.
Which Products Are Affected
The affected products are 0.9% Sodium Chloride Injection, USP, with the following details: brand name is SODIUM CHLORIDE, manufactured by Fresenius Kabi USA, LLC. The product NDCs include 65219-466, 65219-468, 65219-470, 65219-472, and 65219-474. Specific batches affected are: 6402299, 6402300, 6402301, 6402302, 6402303 (expiration date: January 31, 2027); 6402305 and 6402398 (expiration date: February 28, 2027); 6402467 (expiration date: April 30, 2027); and 6402577, 6402578 (expiration date: June 30, 2027). The products were distributed US Nationwide, including Alaska and Puerto Rico. The recall number is D-0426-2026, and the product is for intravenous use as a human prescription drug.
What You Should Do
Consumers and healthcare providers should follow the initial firm notification, which was issued via letter, and contact Fresenius Kabi USA, LLC for further instructions regarding the recalled products. For returns or refunds, reach out to the firm at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930.
Why This Matters
This recall involves medical products essential for patient care, and the lack of assurance of sterility could potentially affect safety in healthcare settings. It highlights the importance of maintaining sterility in prescription drugs.
Source
This information is from the FDA recall database. For more details, visit the FDA website at FDA.gov and reference recall number D-0426-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,702 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.