Recall RadarEpinephrine 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, N…
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.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- American Regent, Inc. — Shirley, NY
- Severity
- Class I — serious
- Reported
- September 16, 2026
- Quantity
- 31,935 30mL-vials
- Recall number
- D-0865-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within the U.S.A
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