American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
- Date
- Sep 3, 2026
- Company
- American Regent, Inc.
- Brand
- American Regent, Inc.
- Product
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
- Reason
- Presence of particulate matter and lack of sterility assurance
- Hazard
- Other
- Source
- FDA
How to identify the product
- FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level.
- Epinephrine Injection, USP is a clear, colorless, sterile solution available in a 30 mL multiple-dose vial containing 1 mg/mL.
- The affected Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide, in the United States.
- Specific NDC numbers, lot numbers, expiration dates and distribution dates can be found in the table below.
- American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products.
- Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.