The FDA lists an ongoing Class II recall, dated 9 September 2026, of Baxter Healthcare's vancomycin injection USP in 5% dextrose, 1 g per 200 mL, in GALAXY single-dose containers. The stated reason is current good manufacturing practice (CGMP) deviations.
A Class II recall means use of the product may cause temporary or medically reversible harm, or that serious harm is remote. The record does not describe a specific defect or report patient harm. The product is a US-market premix; whether it is supplied in India is not stated.
- Check pharmacy stock for the affected Baxter vancomycin 1 g/200 mL GALAXY premix and quarantine it.
- Use alternative vancomycin preparations; this recall concerns manufacturing, not the drug itself.
- Continue vancomycin level monitoring and dosing as usual.
- Report any suspected adverse reaction linked to the product to your pharmacovigilance programme.
Why it matters
Pharmacy teams need to act on product-level recalls even when the drug itself is not in question.
Don't overread it
A Class II manufacturing recall is not a safety signal about vancomycin as a drug.
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