FDA Drug recall D-0581-2026
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 633…
- FDA Drug
- Class III
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class III recall of Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 633… by Fresenius Kabi Usa, citing failed Impurities/Degradations Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0581-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-05-14 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Identifiers
| ndc | 63323-696-02 |
|---|---|
| ndc | 63323-696-25 |
| code_info | Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Ba…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2026%22
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