Epinephrine Injection recall
American Regent, Inc. recalled Epinephrine Injection on September 16, 2026 because of presence of Particulate Matter and Lack of Assurance of Sterility. It was sold nationwide.
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.
What's recalled
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
Quantity: 31,935 30mL-vials
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- American Regent, Inc., Shirley, NY
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- Nationwide
Nationwide within the U.S.A - Status
- Ongoing
- Recall number
- D-0865-2026
- Source
- U.S. Food and Drug Administration
More drugs recalls
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC