The FDA enforcement report lists a Class II recall, dated 9 September 2026, of vasopressin in 0.9% sodium chloride, 40 units in 100 mL, in single-dose containers from Baxter Healthcare. The stated reason is deviation from current good manufacturing practice, and 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 vasopressin is used as a second vasopressor in septic shock. Its supply in India is not established from this record, and no CDSCO action is reported. Units that stock it should check lots and make sure vasopressin can be prepared from vials without delay.
- Check ICU and emergency stock for Baxter premixed vasopressin bags
- Quarantine affected lots and prepare infusions from vials
- Confirm infusion concentrations are clearly labelled when switching preparations
- Report any unexpected haemodynamic response to pharmacovigilance
Why it matters
A recall of a premixed vasopressor can disrupt septic shock protocols if a substitute preparation is not ready.
Don't overread it
A Class II recall for manufacturing deviations is not evidence that patients have been harmed.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for emergency & critical care, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free