The FDA lists an ongoing Class I recall of adrenaline (epinephrine) injection USP, 30 mg/30 mL (1 mg/mL), in 30 mL multiple-dose vials from American Regent. The reasons given are particulate matter, identified as nylon, cellulose, acrylic, polyethylene and glass; broken and leaking vials; and lack of assurance of sterility. The recall was recorded on 16 September 2026.
Class I is the FDA's most serious category, used where exposure could cause serious harm. Particulate matter given intravenously can cause embolic and inflammatory complications, and non-sterile product carries an infection risk.
The 30 mL vial is typically used for preparing infusions in emergency departments, theatres and intensive care. It is not the 1 mL ampoule or autoinjector used for anaphylaxis. Pharmacy and emergency teams should check stock for affected lots against the FDA notice and remove them. The FDA has not stated whether the product is distributed outside the US; in India its availability is unknown.
- Ask pharmacy to check emergency, theatre and ICU stock for American Regent 30 mL adrenaline vials named in the recall.
- Quarantine affected lots and use an alternative presentation for infusions.
- Inspect any multiple-dose vial for particles, cracks or leaks before drawing up.
- Report suspected adverse events linked to affected product through your national reporting system.
Why it matters
Adrenaline infusions are prepared under time pressure, when a visible particle is easy to miss.
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