Fentanyl Citrate Injection Shortage: Current Availability and Manufacturer Updates
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The FDA reports a current shortage of Fentanyl Citrate Injection, with certain presentations from Fresenius Kabi USA currently unavailable and others remaining in supply.
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 "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 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, Fentanyl Citrate) 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
Fentanyl Citrate Injection (Brand Name: FENTANYL CITRATE) is currently listed in a shortage status by the FDA. This medication is categorized for use in Analgesia/Addiction and Pediatric care. The shortage involves specific presentations of the injection dosage form.
Which Manufacturers Are Affected
Fresenius Kabi USA, LLC is the primary manufacturer listed for this shortage. The availability varies by specific product presentation:
- Unavailable: Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11). The manufacturer notes the next release is expected in February 2026.
- Unavailable: Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05). The manufacturer notes the next release is expected in February 2026.
- Available: Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20, 63323-806-01, 63323-806-02, 63323-806-50).
For all presentations, the manufacturer advises checking with wholesalers for current inventory.
Manufacturer Contact Information:
- Fresenius Kabi USA, LLC: 888-386-1300
Why There's a Shortage
The reason for the shortage is officially listed as "Other." No further specific details regarding production delays or supply chain issues were provided in the database.
What Patients Should Do
If you or a family member are prescribed Fentanyl Citrate Injection, please consider the following steps:
- Consult Your Healthcare Provider: Patients should always consult with their doctor or healthcare provider regarding their treatment plan and any potential impact this shortage may have on their care.
- Speak with Your Pharmacist: Pharmacists often have the most up-to-date information on local inventory and can check with various wholesalers.
- Contact the Manufacturer: You may use the contact information provided above to inquire about supply timelines for specific NDCs.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should consult their healthcare provider for all medical decisions and alternative treatment options.
Source
This information is based on the FDA Drug Shortage Database.
Initial Posting Date: 01/01/2012
Last Updated: 02/05/2026
Original source: FDA Official Notice ↗
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