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Regulatory · 03 of 05

FDA lists a Class II recall of one premixed vasopressin infusion

Ask pharmacy to check imported premixed vasopressin stock against the FDA recall and have a vial-based alternative ready.

The FDA enforcement report lists an ongoing Class II recall, dated 9 September 2026, of vasopressin 20 units in 100 mL sodium chloride single-dose containers from Baxter Healthcare, for deviations from current good manufacturing practice.

A Class II recall indicates that use may cause temporary or medically reversible harm, or that serious harm is unlikely. No clinical problem is described in the notice, and whether affected lots reached India is not stated.

  • The recall concerns one premixed vasopressin product, not vasopressin itself.
  • ICU and emergency pharmacies holding imported premixed vasopressin should check lots against the FDA notice.
  • Vasopressin prepared from vials is not affected.
  • No action is needed for patients already treated.

Why it matters

Premixed vasopressin is used in septic shock, where a supply gap must not delay a second vasopressor.

Don't overread it

A manufacturing-practice recall is not a finding that the drug is unsafe.

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