Active recall · Foreign objectUpdated · 1 month ago
American Regent, Inc. recall: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
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. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility. The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass.
What to do
Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Read the official notice, opens in a new tabHave one at home?
Check your pack’s codes and dates against this recall.
Which products
Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
- Dates on pack
- Affected product information: this FDA announcement lists multiple products.
American Regent, Inc.
American Regent
Inc.
30
25128L1C0
25280L1C0
26108L1C0
More detail
Presence of particulate matter and lack of sterility assurance
In the news
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