Recall of 0.9% Sodium Chloride Injection Due to Sterility Concerns
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Fresenius Kabi USA, LLC is voluntarily recalling specific batches of 0.9% Sodium Chloride Injection because of 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, fda, Drugs.
What Happened
Fresenius Kabi USA, LLC is initiating a voluntary recall of certain batches of 0.9% Sodium Chloride Injection, USP, due to a lack of assurance of sterility, as classified by the FDA as a Class II recall.
Which Products Are Affected
The affected products include 0.9% Sodium Chloride Injection, USP, 50 mL x60, with brand name SODIUM CHLORIDE, manufactured by Becton Dickinson and Company and distributed by BD. The specific batches are: Batch# 6402428 with expiration date 10/31/2026, and Batch# 6402481 and 6402482 with expiration date 11/30/2026. The Unit of Sale NDC Number is 17271-701-02, with additional package NDC numbers including 17271-701-03, 17271-701-05, 17271-701-06, and 17271-701-07. The product is a human prescription drug for intravenous use, and the recall affects an unknown quantity distributed US Nationwide, including Alaska and Puerto Rico. The recall number is D-0429-2026.
What You Should Do
Consumers and healthcare providers should immediately check for the affected batches and follow the initial firm notification via letter from Fresenius Kabi USA, LLC. Contact the recalling firm at their address: 3 Corporate Dr, Lake Zurich, IL 60047-8930, for instructions on returns or refunds.
Why This Matters
This recall highlights potential risks associated with non-sterile intravenous drugs, which could lead to health complications, emphasizing the importance of sterility in medical products to ensure patient safety.
Source
FDA Recall Notice D-0429-2026, attributed to the U.S. Food and Drug Administration (FDA).
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 (1,575 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.