Several lots of epinephrine injection vials have been recalled over concerns about their sterility.
American Regent, Inc. recalled three lots of its 30-milliliter multiple-dose epinephrine injection vials, according to a Sept. 3 notice from the U.S. Food and Drug Administration. The products were distributed nationwide as recently as July and are used for emergency treatment of severe allergic reactions, including anaphylaxis.
The recall followed customer complaints about leaking and cracked vials. The company’s investigation found that affected products may contain particulate matter, including glass, nylon, acrylic, polyethylene and cellulosic material.
Which Epinephrine Injections Were Recalled?
The affected products are labeled “Epinephrine Injection, USP.” They are 30 mg/30 mL (1 mg/mL) multiple-dose vials with the following National Drug Code and lot information:
- NDC: 0517-3030-01
- Lot 25128L1C0: Expires August 2026; distributed Sept. 4-Dec. 18, 2025
- Lot 25280L1C0: Expires October 2026; distributed Dec. 16, 2025-April 17, 2026
- Lot 26108L1C0: Expires July 2027; distributed June 15-July 31, 2026
Why Were the Epinephrine Injections Recalled?
The products were recalled after customers reported leaking and cracked vials. American Regent said its investigation found that the affected injections may contain particulate matter. Injecting products containing particles could cause serious adverse health effects.
What to Do If You Have Recalled Epinephrine
Do not use an affected product. Contact your doctor or health care provider for guidance and a replacement. American Regent said it is notifying distributors and customers by letter and arranging for recalled products to be returned and replaced.
Consumers with questions can contact the company at 1-800-645-1706.
This article originally appeared on USA TODAY. USA TODAY Network via Reuters Connect.
This information is for general education and is not a substitute for advice from a qualified health care professional.
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