Fresenius Kabi epinephrine injection recalled for failed impurity specifications
Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- Check your facility or pharmacy inventory for the affected batch numbers: 6133313, 6133314, 6133315, 6133682, 6134812, or 6134813, with expiration dates between June 2026 and April 2027.
- Contact Fresenius Kabi or your pharmacy for instructions on returning or disposing of affected vials.
- Do not use recalled vials for patient treatment.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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)
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 898,050 vials
- Illnesses reported
- None reported
- Manufactured in
- 3 Corporate Dr, N/A, Lake Zurich, IL, United States
- Classification
- Class III
- Recall number
- D-0581-2026
In the FDA's words
- Description
- 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) Failed Impurities/Degradations Specifications 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. Distribution: US Nationwide. Affected quantity: 898,050 vials
- Hazard
- Failed Impurities/Degradations Specifications
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