The FDA enforcement report lists a Class II recall of vasopressin 40 units in 100 mL of 0.9% sodium chloride (0.4 units/mL) in single-dose containers, made by Baxter Healthcare. The stated reason is deviations from current good manufacturing practice; the recall is ongoing and dated 9 September 2026.
Class II means use may cause temporary or medically reversible harm, or that serious harm is remote. No specific defect or harm is described.
Premixed vasopressin bags are used in ICUs and emergency departments for septic shock. Their availability in India is not established here; units elsewhere should check lot numbers with pharmacy.
- ICU and emergency pharmacies using premixed vasopressin bags should check lots against the FDA notice.
- If stock is withdrawn, prepare vasopressin infusions to the unit's standard concentration and label clearly.
- Double-check pump settings when infusion concentration changes.
- The recall concerns manufacturing practice, not the drug's efficacy.
Why it matters
A change in vasopressor concentration during a shortage is a classic source of infusion errors.
Don't overread it
A Class II manufacturing recall is administrative and does not signal a new safety concern with vasopressin.
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