Baxter Healthcare Corporation: Daptomycin, In 0.9% Sodium Chloride Injection, 500 Mg Per

Daptomycin Recall Summary Baxter Healthcare Corporation is recalling Daptomycin in 0.9% Sodium Chloride Injection (500 mg per 50 mL) nationwide due to manufacturing deviations that don't meet quality standards. The recalled product was distributed across all U.S. states, Puerto Rico, and Chile. This is a Class II recall, meaning the product could cause serious health problems or failure of an essential medical function.

Recalling firm
Baxter Healthcare Corporation
Product
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
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/01ce5d5d-1b39-4995-8734-2210cd748562