Recall of 0.9% Sodium Chloride Injection by BD
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Fresenius Kabi USA, LLC is voluntarily recalling 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, fda, Drugs.
Recall of 0.9% Sodium Chloride Injection
What Happened
The recall is due to a lack of assurance of sterility in the product.
Which Products Are Affected
The affected product is 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL), in a 1,000 mL Single Dose freeflex bag. It includes Unit of Sale NDC Number: 17271-701-07, with package NDCs such as 17271-701-02, 17271-701-03, 17271-701-05, 17271-701-06, and 17271-701-07. The specific batch is 24EU10010 with an expiration date of May 31, 2027. The distribution pattern is US Nationwide, Alaska, and Puerto Rico. The recall number is D-0434-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Fresenius Kabi USA, LLC, for further instructions regarding returns or refunds.
Why This Matters
This recall highlights potential risks associated with medical products that may not meet sterility standards, which could affect patient safety in healthcare settings.
Source
Attribution: FDA. For more information, refer to the FDA recall details under event ID 98581.
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 (1,136 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.