Remifentanil Hydrochloride Injection Shortage: Current Availability and Manufacturer Updates

Source: FDA · United States

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Certain presentations of Remifentanil Hydrochloride Injection are currently in shortage, though several versions remain available from major manufacturers.

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 "low" 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, Remifentanil) 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

Remifentanil Hydrochloride Injection (brand names: Ultiva, Remifentanil Hydrochloride) is currently listed in the FDA drug shortage database. This medication is used within the Analgesia/Addiction therapeutic category. While the shortage is ongoing, several presentations remain available to healthcare providers.

Which Manufacturers Are Affected

Two primary manufacturers are involved in the supply of this medication, with varying levels of availability:

Fresenius Kabi USA, LLC

  • 1 mg/1 mL (NDC 63323-725-10): Available. (Note: Check wholesalers for inventory)
  • 1 mg/1 mL (NDC 63323-724-05): Available. (Note: Check wholesalers for inventory)
  • 1 mg/1 mL (NDC 63323-723-03): Unavailable. The manufacturer notes the next release is expected in March 2026.
  • Contact: 888-386-1300

Mylan Institutional, a Viatris Company

  • Ultiva 1 mg/1 mL (NDC 72078-034-01): Available.
  • Ultiva 2 mg (NDC 72078-035-02): Available.
  • Ultiva 5 mg (NDC 72078-036-05): Available.
  • Contact: 800-796-9526

Why There's a Shortage

The source data does not provide a specific reason for the current shortage of the affected presentation. One specific presentation from Fresenius Kabi is not expected to be released until March 2026.

What Patients Should Do

If you or a loved one are scheduled for a procedure involving this medication, please consider the following steps:

  • Consult Your Healthcare Provider: Always discuss your treatment plan and any concerns about medication availability with your doctor or surgical team.
  • Check with Pharmacists: Healthcare facilities and pharmacists can check current inventory through their wholesalers.
  • Contact Manufacturers: For specific questions regarding supply timelines, you may contact the manufacturers at the phone numbers listed above.

Disclaimer: Patients should consult their healthcare provider for all medical advice and treatment options.

Source

Information sourced from the FDA Drug Shortage Database. Initial Posting Date: 06/28/2022
Last Updated: 02/05/2026

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?
Certain presentations of Remifentanil Hydrochloride Injection are currently in shortage, though several versions remain available from major manufacturers.
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 "low" severity. No immediate action required, but stay aware.
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.