FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter dexmedetomidine injection recalled for CGMP manufacturing deviations
What this means
Baxter Healthcare Corporation is recalling specific lots of dexmedetomidine hydrochloride injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lots were distributed nationwide, in Puerto Rico, and Chile.
- Check your facility's inventory against the recalled lot numbers: NC188654, NC188821, NC193658, and NC193702.
- Contact Baxter Healthcare Corporation or your supplier for return instructions.
- Do not use affected units.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0810-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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