Epinephrine recalls

Epinephrine products have been recalled 8 times, most recently on 16 Sep 2026. The recalling company is usually Cardinal Health. The most common reason is manufacturing (cgmp) deviations.

Total recalls8since 2020

Last 12 months3reported

Class I113% of total

Ongoing3latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 1 0May 1 0 0Aug 1 0

Severity split

Class I 1 13%Class II 6 75%Class III 1 13%

Why epinephrine is recalled

Companies

Cardinal Health225%
Mckesson Medical-Surgical Inc. Corporate Office225%
Teva Pharmaceuticals USA113%
American Regent113%
Fresenius Kabi USA113%
International Medication Systems113%

Product types

Allergy Medication8100%

By year

2026338%
2022225%
2021225%
2020113%

Ongoing epinephrine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine	American Regent	Particulate Matter	Nationwide
17 Jun 2026Drug	CLASS III	Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine	Fresenius Kabi USA	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine	International Medication Systems	Sterility	Nationwide

All epinephrine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine	American Regent	Particulate Matter	Nationwide
17 Jun 2026Drug	CLASS III	Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine	Fresenius Kabi USA	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine	International Medication Systems	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg recalledEpinephrine	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg recalledEpinephrine	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Epinephrine Injection USP, 0.3mg recalled by Cardinal HealthEpinephrine	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Epinephrine Injection USP, 0.15 MG recalled by Cardinal HealthEpinephrine	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
13 May 2020Drug	CLASS II	Epinephrine Injection USP, 0.3 mg (Auto-Injector) recalledEpinephrine	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.