Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride… was recalled on August 6, 2026 in cooperation with the U.S. Food and Drug Administration because CGMP Deviations.
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.
Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
Units affected: N/A
Where it was sold: US Nationwide; Puerto Rico; and Chile.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
CGMP Deviations
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Baxter Healthcare Corporation
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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