Baxter Healthcare Corporation: Clindamycin Phosphate In 0.9% Sodium Chloride Injection, 600 Mg Per

Recall Summary Baxter Healthcare is recalling Clindamycin Phosphate in 0.9% Sodium Chloride Injection (600 mg per 50 mL) nationwide due to manufacturing process deviations that don't meet FDA standards. The affected product is the 50 mL single-dose GALAXY Container with NDC 0338-9549-50. The recall impacts patients in all U.S. states, Puerto Rico, and Chile who may have received this injectable antibiotic.

Recalling firm
Baxter Healthcare Corporation
Product
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
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/64cc9daf-ba6d-41d3-8d8c-73a21db70ef4