Epinephrine Injection — Class III drug recall D-0581-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-06-17, distributed nationwide. Failed Impurities/Degradations Specifications
| Recall number | D-0581-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-05-14 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 898,050 vials |
| Reason classes | specification failure |
| NDC | 63323-0696, 63323-0696-02, 63323-0696-25 |
| Lot numbers | 6133313, 6133314, 6133315, 6133682, 6134812, 6134813 |
| Expiration dates | 2026-06, 2026-07, 2026-09, 2027-04 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0581-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.