FDA Drugs recall ·
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only… recall
- Recall number
- D-0581-2026
- Date
- (initiated May 14, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 898,050 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Failed Impurities/Degradations Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0581-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.