FDA DrugsClass III
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka...
Published: June 17, 2026Recall ID: D-0581-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradations Specifications
Product Description & Identification
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)
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Nui › 1 | N0000000209 |
| Openfda › Nui › 2 | N0000000245 |
| Openfda › Nui › 3 | N0000175552 |
| Openfda › Nui › 4 | N0000175555 |
| Openfda › Nui › 5 | N0000175570 |
| Openfda › Nui › 6 | M0003647 |
| Openfda › Upc | 0363323696023 |
| Openfda › Unii | YKH834O4BH |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAOCULAR |
| Openfda › Route › 3 | INTRAVENOUS |
| Openfda › Route › 4 | SUBCUTANEOUS |
| Openfda › Rxcui | 1660014 |
| Openfda › Spl id | e61f344b-7215-425c-9767-fd4210748221 |
| Openfda › Brand name | EPINEPHRINE |
| Openfda › Spl set id | a6afb9e8-1db9-480c-8d31-58c5c870ca49 |
| Openfda › Package ndc › 1 | 63323-696-02 |
| Openfda › Package ndc › 2 | 63323-696-25 |
| Openfda › Product ndc | 63323-696 |
| Openfda › Generic name | EPINEPHRINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Catecholamines [CS] |
| Openfda › Substance name | EPINEPHRINE |
| Openfda › Pharm class epc › 1 | alpha-Adrenergic Agonist [EPC] |
| Openfda › Pharm class epc › 2 | beta-Adrenergic Agonist [EPC] |
| Openfda › Pharm class epc › 3 | Catecholamine [EPC] |
| Openfda › Pharm class moa › 1 | Adrenergic alpha-Agonists [MoA] |
| Openfda › Pharm class moa › 2 | Adrenergic beta-Agonists [MoA] |
| Openfda › Manufacturer name | Fresenius Kabi USA, LLC |
| Openfda › Application number | ANDA213708 |
| Openfda › Is original packager | true |
| Event id | 98997 |
| Address 1 | 3 Corporate Dr |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 60047-8930 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 898,050 vials |
| Reason for recall | Failed Impurities/Degradations Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260514 |
| Initial firm notification | Letter |
| Center classification date | 20260605 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide.