Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Recalled by Fresenius Kabi USA, LLC Due to Cross Contamination with other products: trace amounts of...

Date: November 17, 2020
Company: Fresenius Kabi USA, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.

Affected Products

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Quantity: 13,525 bottles

Why Was This Recalled?

Cross Contamination with other products: trace amounts of lidocaine

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report