Epinephrine Injection recall
FDA recall D-0581-2026 · initiated May 14, 2026
Fresenius Kabi USA, LLC recalled Epinephrine Injection in May 2026 — an FDA Class III recall (D-0581-2026) because Failed Impurities/Degradations Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradations Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 898,050 vials
Details
- 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)
- Recalling company
- Fresenius Kabi USA LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 14, 2026
- FDA report date
- Jun 17, 2026
Frequently asked
- Was Epinephrine Injection recalled?
- Fresenius Kabi USA, LLC recalled Epinephrine Injection in May 2026 — an FDA Class III recall (D-0581-2026) because Failed Impurities/Degradations Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Epinephrine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0581-2026 was: Failed Impurities/Degradations Specifications
- Is a recalled Epinephrine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Epinephrine Injection are affected?
- Distributed: US Nationwide.. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0581-2026.