Something you bought was just recalled. What does that mean?
What happens when something you purchase is recalled? Is it voluntary or mandatory? And what does it mean for you?
Several lots of epinephrine injection vials have been recalled over concerns about their sterility.
American Regent, Inc. has recalled three lots of its 30 ml multiple-dose epinephrine injection vials, according to a Sept. 3 notice from the U.S. Food and Drug Administration.
The affected products were distributed nationwide in the United States as recently as July. The injections are used for emergency treatment of allergic reactions, including anaphylaxis, according to the notice.
The recall was initiated after customers complained of leaking and cracked vials, causing concerns about the product’s sterility.
Here’s what to know.
Which epinephrine injections were recalled?
Three lots of American Regent, Inc.’s 30 mg/30 mL (1 mg/mL) epinephrine injections have been recalled.
The affected products are labeled “Epinephrine Injection, USP” and can be identified by the following information:
- NDC: 0517-3030-01
- Lot: 25128L1C0Expiry: August 2026Distribution date range: Sept. 4 – Dec. 18, 2025
- Lot: 25280L1C0Expiry: October 2026Distribution date range: Dec. 16, 2025 – April 17, 2026
- Lot: 26108L1C0Expiry: July 2027Distribution date range: June 15 – July 31, 2026
Why were epinephrine injections recalled?
The epinephrine injections were recalled after customers reported leaking and cracked vials.
American Regent, Inc. also investigated the issue and determined that the affected products may contain particulate matter including glass, nylon, acrylic, polyethylene and cellulosic.
Administering the affected products containing particulate matter intravenously could cause serious adverse health affects.
What to do if you have recalled epinephrine injections
Any consumers who use the affected products should stop using them and contact their doctor or health care provider.
American Regent, Inc. said is notifying its distributors and customers of the recall by letter and is arranging for of all recalled products to be returned and replaced.
Consumers with questions can contact the company at 1-800-645-1706.
Melina Khan is a national trending reporter for USA TODAY. Keep up with her on X @melinakh and Instagram @bymelinakhan.