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
Reason for Recall
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, re
Date Issued
Category
Food
Status
voluntary
Issuing Agency
FDA CFSAN
What to do if you're affected
- →Check your pantry, refrigerator, and freezer for the specific lot numbers, best-by dates, and UPC codes listed in the recall notice.
- →Do not consume the product — dispose of it or return it to the store for a full refund.
- →Most grocery stores accept recalled food returns without a receipt.
- →Wash any surfaces that may have contacted the recalled product.
- →If you have already consumed the product and feel unwell, contact your healthcare provider.
About the FDA CFSAN
This recall was issued by the FDA's Center for Food Safety and Applied Nutrition (CFSAN), which oversees most packaged foods, produce, seafood, dietary supplements, and bottled water sold in the United States. The FDA monitors the food supply through facility inspections, laboratory testing, import screening, and consumer reports. When a contamination or labeling problem is found, the FDA works with the company on a voluntary recall or requests a mandatory one. Recalls are classified by severity: Class I (reasonable probability of serious harm or death), Class II (possible temporary adverse effects, remote probability of serious harm), Class III (unlikely to cause health effects, but violates regulations).
View all FDA CFSAN recalls →Opens the official government source. Always refer to official sources for the most current information.