Recall: D-0581-2026

Class III - Minor Violations

Class IIIClassification

2026-05-14Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

Product

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

Failed Impurities/Degradations Specifications

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.