Epinephrine recalls
The FDA has published 22 recalls involving Epinephrine since 2012. The latest was reported on 17 Jun 2026. Most were for manufacturing (cgmp) deviations. Mckesson Medical-Surgical Inc. Corporate Office has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls22since 2012
Last 12 months2reported
Class I29% of total
Ongoing5latest 17 Jun 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 2 9%Class II 18 82%Class III 2 9%
Why epinephrine is recalled
Companies
Brands
By year
Ongoing epinephrine recalls
5 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ 1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS III | Epinephrine Professional EMS kits recalled by Focus Health GroupEpinephrine Professional | Focus Health Group | Other | Nationwide |
| Drug | CLASS I | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 15 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
| Drug | CLASS I | EpiPen 2-Pak (Epinephrine) Auto-Injectors 3 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
All epinephrine recalls, newest first
22 totalShould you stop taking Epinephrine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.