Dexmedetomidine Hydrochloride Injection Shortage: Updates on Manufacturer Availability
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The FDA has reported a current shortage of Dexmedetomidine Hydrochloride Injection, an anesthesia medication, primarily due to shipping delays and manufacturer discontinuations.
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, Dexmedetomidine) 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
Dexmedetomidine Hydrochloride Injection is currently listed in shortage by the FDA. This medication, which falls under the therapeutic category of anesthesia, is available under the generic name Dexmedetomidine Hydrochloride Injection and brand names including Dexmedetomidine Hydrochloride and Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride. The shortage affects various presentations, including 4 mcg/mL, 100 mcg/1 mL, 200 mcg/2 mL, and 400 mcg/100 mL concentrations.
This shortage was first posted on April 10, 2020, and was last updated on February 5, 2026.
Which Manufacturers Are Affected
Availability varies significantly across different suppliers:
- Fresenius Kabi USA, LLC: Currently Unavailable for multiple presentations (4 ug/1 mL and 100 ug/1 mL). Contact: 888-386-1300.
- Accord Healthcare Inc.: Currently Unavailable. One presentation has been discontinued, while another has a resupply date that is currently To Be Determined (TBD). Contact: 866-941-7875, option 2.
- Amneal Pharmaceuticals: Currently Available (4 mcg/mL in 50 mL and 100 mL). Contact: 877-835-5472 or 866-525-7270.
- Mylan Institutional, a Viatris Company: Currently Available (100 ug/1 mL). Contact: 800-796-9526.
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.: Currently Available. These products are marketed by Sandoz Inc. (800-525-8747) or distributed by Avenacy (877-283-6229).
- Baxter Healthcare: Currently Available (200 ug/50 mL). Contact: 888-229-0001.
- Par Health, USA LLC: Currently Available (4 ug/1 mL). Contact: 800-828-9393.
Why There's a Shortage
The primary reason cited for the current shortage is a delay in the shipping of the drug. Additionally, Accord Healthcare Inc. has reported the discontinuation of the manufacture of specific presentations of the medication.
What Patients Should Do
Dexmedetomidine Hydrochloride is an injection typically administered by healthcare professionals in clinical or hospital settings for anesthesia. If you or a loved one are scheduled for a procedure requiring this medication, please consider the following steps:
- Consult Your Healthcare Provider: Speak with your doctor or the clinical staff at the facility where the procedure will take place to discuss the availability of the medication.
- Contact Manufacturers: For the most up-to-date information regarding specific supply levels, you may contact the manufacturers listed above using the provided phone numbers.
- Pharmacist Consultation: Hospital pharmacists are often the first to know about supply shifts and can provide information on current inventory.
Disclaimer: Patients should always consult their healthcare provider regarding medication changes or concerns. This article does not provide medical advice or recommend specific alternatives.
Source
Information provided by the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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