Recall: D-0810-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-06Initiated

OngoingStatus

Baxter Healthcare CorporationFirm

Product

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.

Reason

CGMP Deviations

Distribution

US Nationwide; Puerto Rico; and Chile.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.