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Epinephrine injections recalled over sterility concerns
WESH • • business
Key Points:
- American Regent has voluntarily recalled three lots of Epinephrine Injection, USP 30 mg/30 mL multi-dose vials nationwide due to the presence of particulate matter and compromised sterility caused by leaking and cracked vials.
- The particulate matter identified includes nylon, cellulosic, acrylic, polyethylene, and glass, which pose serious health risks such as blood vessel blockage, pulmonary embolism, organ damage, and allergic reactions.
- The recalled lots are 25128L1C0 (expiry August 2026), 25280L1C0 (expiry October 2026), and 26108L1C0 (expiry July 2027), distributed between September 2025 and July 2026 across the United States.
- American Regent has not reported any adverse events linked to the recall as of September 3 and is notifying customers to return or replace the affected products; patients are advised to stop using the recalled epinephrine and consult their healthcare provider.
- Consumers and healthcare professionals with questions about the recall can contact American Regent directly for further information.
