The FDA enforcement report lists a Class II recall, dated 9 September 2026, of vancomycin injection 1 g in 200 mL of 5% dextrose in GALAXY single-dose containers from Baxter Healthcare. The stated reason is deviation from current good manufacturing practice. The recall is ongoing.
Class II means use may cause temporary or medically reversible harm, or that serious harm is unlikely. No specific defect or adverse events are described.
Premixed vancomycin bags are mainly a US hospital product. Whether this presentation is supplied in India is not established from this record, and no CDSCO action is reported. Hospitals that do source it should check lots and be ready to prepare vancomycin from vials.
- Check whether premixed Baxter vancomycin bags are in pharmacy stock
- Quarantine affected lots and switch to vial-prepared infusions
- Keep therapeutic drug monitoring unchanged when switching preparations
- Report unexpected reactions to pharmacovigilance
Why it matters
A recall of a premixed antibiotic can interrupt treatment of serious Gram-positive infections if no alternative preparation is ready.
Don't overread it
A Class II recall for manufacturing deviations is not evidence that patients have been harmed.
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