Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696
Summary
The FDA issued a Class III for Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka by Fresenius Kabi USA, LLC. Reason: Failed Impurities/Degradations Specifications.
Details
Source
Drug Recall
External ID
D-0581-2026
Action Date
2026-06-17
Status
Ongoing
Category
drug
Product Description
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)
Lot/Code Info: Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Quantity Affected: 898,050 vials
Reason for Recall
Failed Impurities/Degradations Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-14
Company
Lake Zurich, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0581-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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