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Class I · Most seriousActive recall

Epinephrine

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Where it was soldNationwide within the U.S.A
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Regent, Inc.
Brand nameEPINEPHRINE
Generic nameEPINEPHRINE
Active ingredient(s)EPINEPHRINE
Distributed by / forAmerican Regent, Inc.
NDC0517-3030-01
Show the full FDA record
Full product labelEpinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Recalling firmAmerican Regent, Inc.
DistributionNationwide within the U.S.A
Quantity31,935 30mL-vials
Recall initiated2026-08-11
Report date2026-09-16
Recall completed—
Recall numberD-0865-2026
ClassificationClass I
FDA statusOngoing
Origin on fileShirley NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.