Home / Dexmedetomidine / United States
US ATC N05CM18 · updated 2 Nov 2026
Dexmedetomidine shortage in United States
Is there a Dexmedetomidine shortage in United States?
Yes. As of 2 Nov 2026, 60 Dexmedetomidine products are reported short in United States, the first since 10 Apr 2020. No return date has been given. Main reason: not stated.
Also short in Italy, Spain, Czechia. All countries.
Affected products in United States
| Country | Product | Company | Since | Expected back | Reason |
|---|---|---|---|---|---|
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) discontinuation | Accord Healthcare Inc. | 10 Apr 2020 | not given | Manufacturing problem Discontinuation of the manufacture of the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | Par Health, USA LLC | 10 Apr 2020 | not given | Other |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) | Eugia US LLC | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) | Fresenius Kabi USA, LLC | 10 Apr 2020 | not given | Increased demand Demand increase for the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) | Mylan Institutional, a Viatris Company | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-758-04) | Somerset Therapeutics, LLC | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) | Somerset Therapeutics, LLC | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) discontinuation | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | 10 Apr 2020 | not given | Manufacturing problem Discontinuation of the manufacture of the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (NDC 0781-3494-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42) | Gland Pharma Limited | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) | Mylan Institutional, a Viatris Company | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Amneal Pharmaceuticals | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Amneal Pharmaceuticals | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) | Par Health, USA LLC | 10 Apr 2020 | not given | Other |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) | Par Health, USA LLC | 10 Apr 2020 | not given | Other |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) | Gland Pharma Limited | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) | Gland Pharma Limited | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-296-10) | Eugia US LLC | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 55150-297-10) | Eugia US LLC | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) | Amneal Pharmaceuticals | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) | Amneal Pharmaceuticals | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (NDC 0781-3495-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) | Mylan Institutional, a Viatris Company | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 80 mcg/20 mL (NDC 0781-3493-95) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 200 mcg/50 mL (NDC 0409-7838-24) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 400 mcg/100 mL (NDC 0409-7853-24) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) | Pfizer Inc. | 10 Apr 2020 | not given | Not stated |
| US | Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) limited | Pfizer Inc. | 10 Apr 2020 | not given | Other |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) | Hikma Pharmaceuticals USA, Inc. | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) discontinuation | Accord Healthcare Inc. | 10 Apr 2020 | not given | Manufacturing problem Discontinuation of the manufacture of the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) | HQ Specialty Pharma | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) | HQ Specialty Pharma | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) | Azurity Pharmaceuticals, Inc | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) | Azurity Pharmaceuticals, Inc | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) | Baxter Healthcare | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) | Baxter Healthcare | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) | HQ Specialty Pharma | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) | HQ Specialty Pharma | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-00) | Fresenius Kabi USA, LLC | 10 Apr 2020 | not given | Distribution or logistics Delay in shipping of the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-20) | Fresenius Kabi USA, LLC | 10 Apr 2020 | not given | Other |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 63323-671-50) | Fresenius Kabi USA, LLC | 10 Apr 2020 | not given | Distribution or logistics Delay in shipping of the drug |
| US | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) | Azurity Pharmaceuticals, Inc | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | Azurity Pharmaceuticals, Inc | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) | Baxter Healthcare | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) | Baxter Healthcare | 10 Apr 2020 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) | Meitheal Pharmaceuticals, Inc. | 10 Apr 2021 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) discontinuation | Accord Healthcare Inc. | 21 Apr 2026 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) discontinuation | Slayback Pharma | 5 Jun 2026 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) discontinuation | Slayback Pharma | 5 Jun 2026 | not given | Not stated |
| US | Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02) discontinuation | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) | 14 Oct 2026 | not given | Not stated |
Source
U.S. Food and Drug Administration (FDA), Drug Shortages via openFDA. Official list. Shortages the FDA lists as current, plus products to be discontinued; one row per package (NDC).