Epinephrine Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIIOngoing
Summary: Fresenius Kabi USA, LLC is recalling 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.
What is being recalled
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)
Why
Failed Impurities/Degradations Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide.
How to tell if yours is affected
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.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0581-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | May 14, 2026 |
| Reported | June 17, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | Lake Zurich, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 898,050 vials |
More recalls from Fresenius Kabi USA, LLC · all drug recalls · recalls from May 2026