Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramusc
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Event record
- severitySevere
- typerecall
- placeShirley, NY, United States
- countryUS
- sourceU.S. Food and Drug Administration (openFDA)
- first seen2026-09-16
- rendered2026-10-14 04:21 UTC
- firmAmerican Regent, Inc.
- distributionNationwide within the U.S.A
What to do
- Check the model, batch and serial number against the official notice.
- Stop using the product and follow the stated remedy.
- Report incidents to the national market surveillance authority.
Who is behind this page
U.S. Food and Drug Administration (openFDA) published the record behind this page. Waarning aggregates public feeds, keeps the issuing body named and links to the original entry. Follow the instructions of your local authorities — this page is not a warning issued by Waarning.
Everything about this warning type
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Frequently asked questions
Who reported this?
U.S. Food and Drug Administration (openFDA) published the record behind this page. Waarning does not issue warnings of its own.
Where did this happen?
Shirley, NY, United States.
What should I do?
Check the model, batch and serial number against the official notice. Stop using the product and follow the stated remedy. Report incidents to the national market surveillance authority.