FDAClass III · Drug · Recalled June 17, 2026

Epinephrine Injection recall — Fresenius Kabi USA, LLC

Hazard: Failed Impurities/Degradations Specifications

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0581-2026
Brand: Fresenius Kabi USA
Classification: Class III
Units affected: 898,050 vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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)

Affected products

Epinephrine Injection

Companies & origin

Recalling firm location: Lake Zurich, IL, United States
Firm address: 3 Corporate Dr, N/A, 60047-8930

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Distribution: US Nationwide.
Firm notified the public via: Letter
FDA event ID: 98997
Recall initiated: May 14, 2026
FDA classified: June 5, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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