FDA recall D-0821-2026

Product

Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.

Reason for recall

CGMP Deviations

Distribution

US Nationwide; Puerto Rico; and Chile.

Key facts

Status

Ongoing

Initiation date

2026-08-06

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2026