Baxter Healthcare Corporation: Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Injection, 400 Mcg Per
Recall Summary Baxter Healthcare is recalling Dexmedetomidine Hydrochloride injection (a prescription sedative medication) distributed nationwide in the U.S., Puerto Rico, and Chile due to manufacturing process deviations that don't meet federal standards. The affected product is the 400 mcg per 100 mL version in Galaxy containers. This is a Class II recall, meaning the product could potentially cause adverse health effects.
- Recalling firm
- Baxter Healthcare Corporation
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide; Puerto Rico; and Chile.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/61cf49d1-8d19-47ff-99f2-2bfa8d8e805e