Sterile Water Injection Shortage: Latest Updates on Availability and Manufacturer Supply

Source: FDA · United States

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The FDA reports an ongoing shortage of Sterile Water Injection. While certain presentations remain available from Fresenius Kabi USA, supply may be limited at the wholesaler level.

What this FDA drug-shortage notice tells you, and what most readers miss

This notice was issued by FDA on February 11, 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 — Drug Shortages — 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.

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 drug-shortage notice 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 (drug-shortage, fda, medication, Sterile Water Injection) 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.

What's in Shortage

Sterile Water Injection (brand name: STERILE WATER) is currently listed in a shortage status. This product is an injection used within the "Other" therapeutic category. The shortage was initially posted on November 23, 2021, and the most recent update was provided on February 5, 2026.

Which Manufacturers Are Affected

Currently, the following manufacturer information is available regarding supply status:

  • Fresenius Kabi USA, LLC
    • Status: Available
    • Notes: The manufacturer recommends checking with wholesalers for current inventory levels.
    • Contact Info: 888-386-1300
    • Available Presentations:
      • Sterile Water For Injection In Plastic Container, 1 mL/1 mL (NDC 63323-185-20)
      • Sterile Water For Injection In Plastic Container, 1 mL/1 mL (NDC 63323-185-50)
      • Sterile Water For Injection In Plastic Container, 1 mL/1 mL (NDC 63323-185-10)
      • Sterile Water, 1000 mL/1000 mL (NDC 63323-178-76)

Why There's a Shortage

The source data provided by the FDA does not list a specific reason for the current shortage of Sterile Water Injection.

What Patients Should Do

If you are affected by this shortage, please consider the following practical steps:

  • Consult Your Healthcare Provider: Discuss your treatment requirements with your doctor or healthcare professional. Do not make changes to your medication regimen without medical guidance.
  • Talk to Your Pharmacist: Pharmacists can provide information on local stock levels and may be able to coordinate with wholesalers to secure necessary supply.
  • Contact the Manufacturer: For specific questions regarding product availability, you may contact Fresenius Kabi USA, LLC at 888-386-1300.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should always consult with their healthcare provider regarding medical concerns and treatment options.

Source

Information sourced from the FDA Drug Shortage Database.

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice about?
The FDA reports an ongoing shortage of Sterile Water Injection. While certain presentations remain available from Fresenius Kabi USA, supply may be limited at the wholesaler level.
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 Drug Shortages updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.