FDA Recall: American Regent, Inc. Epinephrine Injection, USP 30
Source: FDA
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FDA Recall: American Regent, Inc. Epinephrine Injection, USP 30

American Regent, Inc. • September 04, 2026

American Regent Epinephrine Injection Recall: FDA Alert for Particulate Matter & Sterility Concerns

Urgent Safety Notice: American Regent, Inc. has voluntarily recalled three U.S. lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. Do not administer products from the affected lots—return or dispose of them immediately.

Reason for the American Regent Epinephrine Injection Recall

Following customer complaints, American Regent identified cracked or leaking vials that contained visible particulate matter. Laboratory analysis confirmed the particles were nylon, cellulosic fibers, acrylic, polyethylene and glass, indicating the product’s sterility could no longer be ensured.

Potential Health Hazards of Contaminated Epinephrine Injections

  • Blockage or clotting of blood vessels, which may result in pulmonary embolism, organ damage or death
  • Local vein irritation and inflammatory reactions at the injection site
  • Exacerbation of existing infections and possible allergic responses
  • Increased contamination risk from compromised (cracked) vials

No injuries or adverse events had been reported to American Regent as of the announcement date (September 3, 2026).

Affected NDC, Lot Numbers & Distribution Dates

Product NDC Lot Expiration Distributed (Start–End)
Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) 0517-3030-01 25128L1C0 Aug 2026 04 Sep 2025 – 18 Dec 2025
25280L1C0 Oct 2026 16 Dec 2025 – 17 Apr 2026
26108L1C0 Jul 2027 15 Jun 2026 – 31 Jul 2026

Sources

Required Actions for Healthcare Facilities & Patients

  • Quarantine and stop using vials from the recalled lots immediately.
  • Arrange product return for credit or replacement through American Regent customer service.
  • Report any suspected injuries to a healthcare provider and to FDA MedWatch online or via 1-800-332-1088.

American Regent Contact Information

Official Images from the Recall

Recalled American Regent Epinephrine Injection 30 mg/30 mL vial
Source: FDA

Frequently Asked Questions

Which lots of American Regent Epinephrine Injection are included in the FDA recall?
Lots 25128L1C0, 25280L1C0 and 26108L1C0 bearing NDC 0517-3030-01 have been recalled.
Why is American Regent recalling its Epinephrine Injection vials?
Cracked or leaking vials with particulate matter compromise product sterility and pose serious injection-related risks.
What should hospitals do with recalled American Regent Epinephrine Injection vials?
Immediately quarantine the affected vials, discontinue use and coordinate returns with American Regent for credit or replacement.
Have any adverse events been linked to the recalled American Regent Epinephrine Injection?
No adverse events had been reported to American Regent as of September 3, 2026.
How can clinicians obtain a refund or replacement for recalled American Regent Epinephrine Injection?
Call American Regent customer service at 800-645-1706 to receive return shipping instructions and reimbursement options.
How do I report side effects possibly caused by American Regent Epinephrine Injection?
Submit a report to FDA MedWatch online or call 1-800-332-1088 to request a mail or fax form.

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