Class IIDrug
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride… recall
Summary
Baxter Healthcare Corporation is recalling Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection (drug). According to the FDA report, the reason is: CGMP Deviations. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Lot / code info
- Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
- Quantity
- N/A
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Recalling company
- Baxter Healthcare Corporation, Deerfield, IL United States
- Recall started
- August 6, 2026
- FDA report date
- September 9, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0810-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Baxter Healthcare Corporation) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.