Reported Jun 17, 2026 · Ongoing
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC…
Fresenius Kabi USA, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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)
- Lot codes and dates
Batch # 61333136133314
- Exp Date
06/2026Batch # 6133315
- Exp Date
07/2026Batch # 6133682
- Exp Date
09/2026Batch # 61348126134813
- Exp Date04/2027
- Amount recalled
- 898,050 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradations Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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