Fresenius Kabi Sodium Chloride Injection Recall
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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.
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, fda, Drugs.
Recall Article
What Happened
Fresenius Kabi USA, LLC is voluntarily recalling certain batches of 0.9% Sodium Chloride Injection, USP, because of a lack of assurance of sterility, as initiated by the firm.
Which Products Are Affected
The affected products are 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) in 500 mL Single Dose freeflex bags. Specific NDCs include Unit of Use: 65219-432-20 and Unit of Sale: 65219-432-85. Additional NDCs from the product data are 65219-328 and 65219-432, with package NDCs: 65219-432-20, 65219-432-85, 65219-328-10, and 65219-328-50. The recall involves Batch# 23DU10004 with expiration date 04/30/2026 and Batch# 23HU10006 with expiration date 06/30/2026. These products were distributed US Nationwide, including Alaska and Puerto Rico. The product quantity is not specified in the recall details.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter. Contact Fresenius Kabi USA, LLC at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930, for information on returns or refunds related to this recall. The official recall number is D-0432-2026.
Why This Matters
This recall is significant because a lack of sterility in intravenous drugs could potentially lead to health risks, emphasizing the importance of product safety in medical treatments.
Source
FDA Recall Notice for event ID 98581, available via FDA resources.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,454 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.