FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Daptomycin injection recalled for manufacturing quality deviations
What this means
Baxter Healthcare is recalling one lot of Daptomycin in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lot (NC193856, expiring 04/18/2028) was distributed nationwide, Puerto Rico, and Chile.
- Check your pharmacy records or hospital inventory for Daptomycin lot NC193856.
- Do not use this lot. Quarantine and return it to your supplier or Baxter.
- Contact your healthcare provider or pharmacy if you received this lot.
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
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2026More Baxter recalls
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- 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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