FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Clindamycin Injection recalled for manufacturing quality deviations
What this means
Baxter Healthcare has recalled three specific lots of Clindamycin Injection USP (900 mg per 50 mL) due to deviations from Good Manufacturing Practice (CGMP) standards during production. The affected lots were distributed nationwide, Puerto Rico, and Chile. No injuries have been reported.
- Check your facility's inventory for the affected lot numbers: NC185424 (exp. 2/12/2027), NC185479 (exp. 2/13/2027), or NC193948 (exp. 10/23/2027).
- Contact Baxter Healthcare or your supplier for instructions on return or disposal of affected units.
- Do not use clindamycin from these lots.
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
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0815-2026More 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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