FDA-Drug2026-06-17Class IIICHEMICAL
Fresenius Kabi epinephrine injection recalled for failed impurity specifications
OTHERNationwide distribution
Fresenius Kabi epinephrine injection recalled for impurity concerns
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.
Hazard
Failed Impurities/Degradations Specifications
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 USA, LLC recalls
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
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