Reported Sep 16, 2026 · Ongoing
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion,…
American Regent, Inc.
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 5 Ramsay Rd · Shirley, NY · 11967-4701
Is this the product you have?
- 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
- Lot codes and dates
- Lots
25128L1C0Exp. August 31202625280L1C0Exp. October 31202626108L1C0Exp. July 312027
- Lots
- Amount recalled
- 31,935 30mL-vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particluate Matter and Lack of Assurance of Sterility. Customer complaints of broken and leaking vials. Firm investigation reported presence of glass particulates.
The agency has not ranked the risk yet — treat the notice as a caution.
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