# FDA recall D-0581-2026

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2026-05-14.

## 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 for recall

Failed Impurities/Degradations Specifications

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0581-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-14
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0581-2026

## Citation

> MORVS. FDA recall D-0581-2026. Retrieved 2026-10-25 from https://api.morvs.ai/recall/D-0581-2026. Source: US FDA. Licensed CC0.

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