Epinephrine Injection recall — Fresenius Kabi USA, LLC
Failed Impurities/Degradations Specifications
Company / brand: Fresenius Kabi USA
Affected product: Epinephrine Injection
Official ID D-0581-2026 · Official record ↗
Notice names this product. Fresenius Kabi USA’s Epinephrine Injection is named in FDA Class III recall D-0581-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Impurities/Degradations Specifications Identifying details: 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.. Units affected: 898,050 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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)
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Impurities/Degradations Specifications
Company / brand: Fresenius Kabi USA
Affected product: Epinephrine Injection
Official ID D-0581-2026 · Official record ↗
See all Fresenius Kabi USA recalls →
Found something wrong or missing? Report a data error.
Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.