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 good manufacturing practices (CGMP) during production. The affected lot (NC188692, expiring 11/22/2027) was distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.
- Check your facility's inventory for lot NC188692 with expiration date 11/22/2027.
- Contact your pharmaceutical supplier or Baxter Healthcare for return and replacement instructions.
- Do not use the affected 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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0807-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- 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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