Fresenius Kabi Compounding Recalls Vancomycin HCl Injection Due to Sterility Concerns

Source: FDA · United States

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Fresenius Kabi Compounding, LLC has issued a voluntary nationwide recall for 1,578 bags of Vancomycin HCl injection over concerns regarding a lack of assurance of sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Fresenius Kabi Compounding, LLC, operating as Fagron Sterile Services in Canton, MA, has initiated a voluntary recall of Vancomycin HCl injection products. The recall was triggered due to a lack of assurance of sterility, which poses a potential risk to patient safety. The FDA classified this as a Class II recall on February 13, 2026, following the firm's initial notification on February 5, 2026.

Which Products Are Affected

The recall affects 1,578 bags of the following medication distributed nationwide across the United States:

  • Product Name: vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP
  • NDC: 71506-016-59
  • Lot Number: C274-000049628
  • Expiration Date: 3-May-26
  • Manufacturer/Labeler: Fagron Sterile Services / Fresenius Kabi Compounding, LLC

What You Should Do

Healthcare providers and facilities should immediately examine their stock to identify and quarantine the affected lot. Fresenius Kabi Compounding, LLC has initiated notification to customers via letter. For further information regarding the return process or clinical concerns, stakeholders can contact the firm at their facility located at 20 Dan Rd, Canton, MA 02021.

Why This Matters

Injectable medications that lack assurance of sterility present a significant health hazard, as they can introduce contaminants directly into a patient's bloodstream, potentially leading to serious infections or life-threatening complications.

Source

This report is based on official recall data provided by the FDA under Recall Number D-0336-2026.

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 Compounding, LLC has issued a voluntary nationwide recall for 1,578 bags of Vancomycin HCl injection over concerns regarding a lack of assurance of sterility.
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 "high" severity. Take precautions and monitor for updates.
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.