Dexmedetomidine recalls

The FDA has published 4 recalls involving Dexmedetomidine since 2019. The latest was reported on 9 Sep 2026. Fresenius Kabi USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2019

Last 12 months1reported

Class I250% of total

Ongoing1latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 1Sep 0 0

Severity split

Class I 2 50%Class II 2 50%Class III 0 0%

Why dexmedetomidine is recalled

Companies

By year

2026125%
2020250%
2019125%

Ongoing dexmedetomidine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Dexmedetomidine Hydrochloride recalled by Baxter Healthcare	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

All dexmedetomidine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Dexmedetomidine Hydrochloride recalled by Baxter Healthcare	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020Drug	CLASS I	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled	Fresenius Kabi USA	Other	Nationwide
2 Sep 2020Drug	CLASS I	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled	Fresenius Kabi USA	Other	Nationwide
1 May 2019Drug	CLASS II	Dexmedetomidine 400 mcg in NS, Made by: Enterprise Pharmacy recalled	CMC Enterprise Pharmacy	Sterility	NC

Should you stop taking Dexmedetomidine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.