Agency classClass IIOur severity:Severe FDA (Drugs)·D-0810-2026·Announced 2026-09-09

Baxter Recalls Dexmedetomidine Hydrochloride Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling specific lots of Dexmedetomidine Hydrochloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Per the rubric, FDA Class II recalls are assigned a severity score of 4.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling specific lots of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection. The product is a prescription-only intravenous medication packaged in 100 mL single-dose containers. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations.

The affected lots are NC188654 (expiration date 08/31/2027), NC188821 (expiration date 09/30/2027), and NC193658 and NC193702 (expiration date 01/31/2028). The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If the product is found, it should be quarantined and not administered. The recall is ongoing, and Baxter Healthcare has notified customers via letter.

The recalled product

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.
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Prescription Injection
Hazard: cgmp-deviations

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

Lot # NC188654
Exp Date: 08/31/2027
Lot # NC188821
Exp Date: 09/30/2027
Lot # NC193658
NC193702
Exp Date: 01/31/2028.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Healthcare Corporation

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