Fentanyl Citrate Injection Shortage: FDA Update
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.
Fentanyl Citrate Injection is experiencing a current shortage, affecting various presentations from multiple manufacturers, with some options available and others unavailable.
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, Fentanyl Citrate 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 Fentanyl Citrate Injection, with brand name FENTANYL CITRATE. It is available in injection dosage form and falls under the therapeutic categories of Analgesia/Addiction and Pediatric. The shortage status is current, with the initial posting date of January 1, 2012, and last updated on April 2, 2026.
Which Manufacturers Are Affected
Several manufacturers are impacted by this shortage:
- Fresenius Kabi USA, LLC: Unavailable for Fentanyl Citrate Preservative Free, Injection, 0.05 mg/1 mL (NDC 63323-806-01), with next release in May 2026. Contact: 888-386-1300.
- Fresenius Kabi USA, LLC: Unavailable for Fentanyl Citrate Preservative Free, Injection, 0.05 mg/1 mL (NDC 63323-806-50), with next release in May 2026. Contact: 888-386-1300.
- Hospira, Inc., a Pfizer Company: Available for Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28). Contact: 844-646-4398.
- Hospira, Inc., a Pfizer Company: Available for Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61). Contact: 844-646-4398.
- Hospira, Inc., a Pfizer Company: Unavailable for Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25), with next delivery in April 2026 and estimated recovery in June 2026. Contact: 844-646-4398.
- Fresenius Kabi USA, LLC: Available for Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11). Contact: 888-386-1300.
- Hospira, Inc., a Pfizer Company: Limited Availability for Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31), with next delivery and estimated recovery in June 2026 due to manufacturing delay. Contact: 844-646-4398.
- Fresenius Kabi USA, LLC: Unavailable for Fentanyl Citrate Preservative Free, Injection, 0.05 mg/1 mL (NDC 63323-806-02), with next release in May 2026. Contact: 888-386-1300.
- Fresenius Kabi USA, LLC: Unavailable for Fentanyl Citrate Preservative Free, Injection, 0.05 mg/1 mL (NDC 63323-806-05), with next release not available. Contact: 888-386-1300.
- Hospira, Inc., a Pfizer Company: Available for Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22). Contact: 844-646-4398.
- Fresenius Kabi USA, LLC: Unavailable for Fentanyl Citrate Preservative Free, Injection, 0.05 mg/1 mL (NDC 63323-806-20), with next release in May 2026. Contact: 888-386-1300.
Why There's a Shortage
The reason for the shortage is listed as 'Other.' No additional specific details were provided in the source.
What Patients Should Do
Patients who rely on Fentanyl Citrate Injection should speak with their pharmacist to check for availability and discuss options. They may also contact the relevant manufacturer for more information. Remember, patients should consult their healthcare provider for any guidance on their treatment. This article does not provide medical advice.
Source
This information is sourced from the FDA Drug Shortages Database, with the shortage initially posted on January 1, 2012, and last updated on April 2, 2026.
Original source: FDA Official Notice ↗
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