Shortage of Remifentanil Hydrochloride Injection

Source: FDA · United States

Areazine synthesizes this FDA drug-shortage notice directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

The FDA reports a current shortage of Remifentanil Hydrochloride Injection, with some presentations available from certain manufacturers and others unavailable, as last updated on April 3, 2026.

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

This notice was issued by FDA on April 7, 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 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 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 Hydrochloride 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

The drug in shortage is Remifentanil Hydrochloride Injection, with brand names ULTIVA and REMIFENTANIL HYDROCHLORIDE. It is an injection dosage form in the therapeutic category of Analgesia/Addiction. The shortage status is current, first posted on June 28, 2022, and last updated on April 3, 2026.

Which Manufacturers Are Affected

  • Mylan Institutional, a Viatris Company: This manufacturer has the following presentations available: Ultiva Injection 2 mg (NDC 72078-035-02), Ultiva Injection 1 mg/1 mL (NDC 72078-034-01), and Ultiva Injection 5 mg (NDC 72078-036-05). Contact them at 800-796-9526.
  • Fresenius Kabi USA, LLC: This manufacturer has the following: Remifentanil Hydrochloride Injection 1 mg/1 mL (NDC 63323-725-10) available, with a note to check wholesalers for inventory; Remifentanil Hydrochloride Injection 1 mg/1 mL (NDC 63323-723-03) unavailable, with next release in April 2026 and a note to check wholesalers; and Remifentanil Hydrochloride Injection 1 mg/1 mL (NDC 63323-724-05) available, with a note to check wholesalers for inventory. Contact them at 888-386-1300.

Why There's a Shortage

No specific reason was given for the shortage.

What Patients Should Do

Patients who rely on this medication should talk to their pharmacist about availability and options. They can also contact the relevant manufacturer for more information. Remember, patients should consult their healthcare provider for any guidance, as this article does not provide medical advice.

Source

This information is 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 a current shortage of Remifentanil Hydrochloride Injection, with some presentations available from certain manufacturers and others unavailable, as last updated on April 3, 2026.
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.