Fresenius Kabi Compounding Recalls Acyclovir Sodium Injection Due to Sterility Concerns

Source: FDA · United States

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Fresenius Kabi Compounding, LLC has voluntarily recalled 1,057 bags of acyclovir sodium injection distributed nationwide due to 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) has initiated a voluntary recall of acyclovir sodium added to 0.9% Sodium Chloride Injection. The recall was prompted by a lack of assurance of sterility for the affected lot, which could pose significant health risks to patients receiving the intravenous medication.

Which Products Are Affected

The recall involves specific bags of acyclovir sodium for intravenous use. The following details identify the affected product:

  • Product Name: acyclovir sodium, 200 mg (200mg added to 100 mL), 0.9% Sodium Chloride Injection, USP
  • Packaging: Single-Use Bag
  • NDC: 71506-035-56
  • Lot Number: C274-000049124
  • Expiration Date: 28-Feb-26
  • Quantity: 1,057 bags
  • Distribution: Distributed nationwide across the United States.

What You Should Do

Healthcare providers and medical facilities should immediately inspect their inventory for the affected lot number (C274-000049124). Any units from this lot should be quarantined and not administered to patients. The firm initiated the recall via notification letters; facilities should follow the specific instructions provided in those communications for the return or disposal of the affected products.

Why This Matters

A lack of assurance of sterility in an intravenous drug is a serious safety concern. Contaminated products injected directly into the bloodstream can lead to severe infections, systemic illness, or other life-threatening medical complications.

Source

This information is based on official recall data provided by the FDA (Recall Number: D-0333-2026).

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 voluntarily recalled 1,057 bags of acyclovir sodium injection distributed nationwide due to 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.