Class IDrug
Epinephrine Injection recall
Summary
American Regent, Inc. is recalling Epinephrine Injection (drug). According to the FDA report, the reason is: 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. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
American Regent is recalling Epinephrine Injection 30 mL multiple-dose vials because particles (nylon, cellulosic, acrylic, polyethylene and glass) were found, sterility can't be assured, and some vials were broken or leaking.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously. Broken or leaking vials and lack of sterility assurance add an infection risk on top of the particulate concern.
Who should pay attention
Hospital, clinic and pharmacy staff who stock epinephrine 30 mL vials.
Distribution in the FDA report: Nationwide within the U.S.A
How to check your product
Check the lot number and expiration date on the vial and carton.
Codes listed by the FDA: Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- Product
- Epinephrine 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
- Reason
- 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.
- Lot / code info
- Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
- Quantity
- 31,935 30mL-vials
- Distribution
- Nationwide within the U.S.A
- Recalling company
- American Regent, Inc., Shirley, NY United States
- Recall started
- August 11, 2026
- FDA report date
- September 16, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0865-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (American Regent, Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.