FDA-Drug2026-06-17Class IIICHEMICAL
Fresenius Kabi epinephrine injection recalled for failed impurity specifications
What this means
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.
- 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.
The agency's original wording
Hazard
Failed Impurities/Degradations Specifications
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
898,050 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0581-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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