Remifentanil Hydrochloride Injection Shortage: Current Availability and Manufacturer Updates

Drug Shortages low FDA · · United States

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

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

Source: FDA Official Notice

Frequently Asked Questions

What is this drug shortages alert 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 alerts?
Browse all drug shortages alerts on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.