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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
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 23, 2026 at 11:04 PM UTC.
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