FDA recall, , Low risk
Fresenius Kabi Epinephrine Injection
Epinephrine Injection failed impurities and degradations specifications.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, recalled Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, because it failed impurities and degradations specifications. The recall began May 14, 2026, and was added to the FDA's Enforcement Report on June 5, 2026. The product was distributed nationwide in the United States.
The out-of-specification results were obtained at the 18-month stability test. The product is described as Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial
- NDC
- 63323-696-02
- 63323-696-25
- Lot code
- 6133313
- 6133314
- 6133315
- 6133682
- 6134812
- 6134813
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Fresenius Kabi USA, LLCLake Zurich, Illinois
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98997
- Recall number
- D-0581-2026
- Quantity recalled
- 898,050 vials
All recalls from Fresenius Kabi USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
