Class III · Lower riskActive recall
Epinephrine
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberBatch # 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.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradations Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byFresenius Kabi USA, LLC
| Brand name | EPINEPHRINE |
| Generic name | EPINEPHRINE |
| Active ingredient(s) | EPINEPHRINE |
| Distributed by / for | Fresenius Kabi USA, LLC |
| NDC | 63323-696-02 |
Show the full FDA record
| Full product label | 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 firm | Fresenius Kabi USA, LLC |
| Distribution | US Nationwide. |
| Quantity | 898,050 vials |
| Recall initiated | 2026-05-14 |
| Report date | 2026-06-17 |
| Recall completed | — |
| Recall number | D-0581-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Lake Zurich IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.