FDA-Drug2026-09-09Class IIPROCESSING DEFECT

Baxter Vancomycin Injection recalled for CGMP manufacturing deviations

OTHERNationwide distributionDrugs

What this means

Baxter Healthcare Corporation is recalling five lots of Vancomycin Injection USP in 5% Dextrose due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected lots were distributed nationwide, in Puerto Rico, and Chile.

  • If you are a healthcare facility or pharmacy, check your inventory for the affected lot numbers: NC188678, NC188814, NC188944, NC193610, or NC193665.
  • Contact Baxter Healthcare Corporation or your pharmaceutical supplier for instructions on returning or disposing of affected product.
  • Do not use the recalled product.
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
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0805-2026

More Baxter recalls

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