Information
Fresenius Kabi USA Recalls Epinephrine Injection
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0581-2026Drug / Pharmaceutical
Fresenius Kabi USA Recalls Epinephrine Injection
Fresenius Kabi USA, LLC · Class III — Regulatory
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)
Reason for Recall
Failed Impurities/Degradations Specifications
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Fresenius Kabi USA, LLC initiated a Class III recall of a pharmaceutical product on May 14, 2026 affecting 898,050 vials. Failed Impurities/Degradations Specifications. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed in US Nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination and Fresenius Kabi USA recalls.