Epinephrine Injection recall
FDA recall D-0865-2026 · initiated Aug 11, 2026
American Regent, Inc. recalled Epinephrine Injection in Aug 2026 — an FDA Class I recall (D-0865-2026) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
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.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 31,935 30mL-vials
Details
- 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
- Recalling company
- American Regent, Inc.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S.A
- Initiated
- Aug 11, 2026
- FDA report date
- Sep 16, 2026
Frequently asked
- Was Epinephrine Injection recalled?
- American Regent, Inc. recalled Epinephrine Injection in Aug 2026 — an FDA Class I recall (D-0865-2026) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Epinephrine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0865-2026 was: 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.
- Is a recalled Epinephrine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Epinephrine Injection are affected?
- Distributed: Nationwide within the U.S.A. The recall covers these lots — Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0865-2026.