Fresenius Kabi Sodium Chloride Injection Recall

Source: FDA · United States

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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.