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 month

Severity split

Class I 2 9%Class II 18 82%Class III 2 9%

By year

Ongoing epinephrine recalls

5 active

All epinephrine recalls, newest first

22 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIEpinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrineFresenius Kabi USAPotency & AssayNationwide
DrugCLASS IIEpinephrine Injection, USP, 1 mg/ 1 mg/mL) recalledEpinephrineInternational Medication SystemsSterilityNationwide
DrugCLASS IIAdrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalinHenry Schein Inc. and Glove Club HSI GlovesPackaging DefectsNationwide
DrugCLASS IIIEpinephrine Professional EMS kits recalled by Focus Health GroupEpinephrine ProfessionalFocus Health GroupOtherNationwide
DrugCLASS IIEPINEPHrine Injection, USP, 1 mg/ (100 mcg/mL) syringe recalledNephron Sterile Compounding CenterSterilityNationwide
DrugCLASS IIEPINEPHrine Injection, USP, 1 mg/ (10 mcg/mL) syringes recalledNephron Sterile Compounding CenterSterilityNationwide
DrugCLASS IIAdrenalin (epinephrine injection, USP) 30 mg recalledAdrenalinMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIEpi-pen 2-PAK (epinephrine injection, USP) recalledEpipenMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIEPI-Pen Jr, 2-PAK, (epinephrine injection recalledEpipenMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIEpinephrine Injection, USP, Single-Dose Auto-Injectors 15 mg recalledEpinephrineMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide

Should 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.