Remifentanil Hydrochloride Injection Shortage: Current Availability and Manufacturer Updates
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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 April 6, 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 mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are drug-shortage, fda, medication, Remifentanil.
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 ↗
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