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FDA · Drugs ·

Epinephrine Injection recall

Fresenius Kabi USA, LLC recalled Epinephrine Injection on June 17, 2026 because of failed Impurities/Degradations Specifications. It was sold nationwide.

Why it was recalled

Failed Impurities/Degradations Specifications

What's recalled

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Quantity: 898,050 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Fresenius Kabi USA, LLC, Lake Zurich, IL
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0581-2026
Source
U.S. Food and Drug Administration

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