Epinephrine recalls

The FDA has published 36 recalls involving Epinephrine since 2012. The latest was reported on 16 Sep 2026. Most were for sterility. 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 recalls36since 2012

Last 12 months3reported

Class I38% of total

Ongoing6latest 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 3 8%Class II 30 83%Class III 3 8%

Why epinephrine is recalled

Companies

Brands

By year

202638%
202413%
2023514%
20221336%
2021411%
202013%
201826%
201738%
201613%
201413%

Ongoing epinephrine recalls

6 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
19 Apr 2023Drug	CLASS III	Epinephrine Professional EMS kits recalled by Focus Health GroupEpinephrine Professional	Focus Health Group	Other	Nationwide
10 May 2017Drug	CLASS I	EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg recalledEpipen	Meridian Medical Technologies a Pfizer	Other	Nationwide
10 May 2017Drug	CLASS I	EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg recalledEpipen	Meridian Medical Technologies a Pfizer	Other	Nationwide

All epinephrine recalls, newest first

36 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
28 Feb 2024Drug	CLASS II	Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin	Henry Schein Inc. and Glove Club HSI Gloves	Packaging Defects	Nationwide
6 Sep 2023Drug	CLASS II	EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	EPINEPHrine 8mg/ added to dextrose 5%, 32 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	EPINEPHrine 4mg/ added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
19 Apr 2023Drug	CLASS III	Epinephrine Professional EMS kits recalled by Focus Health GroupEpinephrine Professional	Focus Health Group	Other	Nationwide
27 Jul 2022Drug	CLASS II	EPINEPHrine Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	EPINEPHrine Injection, USP, 0.1 mg/ (10 mcg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Adrenalin (epinephrine injection, USP) 30 mg recalledAdrenalin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Epi-pen 2-PAK (epinephrine injection, USP) recalledEpipen	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	EPI-Pen Jr, 2-PAK, (epinephrine injection recalledEpipen	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	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
15 Jun 2022Drug	CLASS II	Epinephrine, ABJT 0.1 mg/mL, 20GX1.5 recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2022Drug	CLASS II	EPINEPHrine Injection, USP, 0.1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022Drug	CLASS II	Epinephrine Injection, USP, 1 mg recalled by Nephron Sterile Compounding	Nephron Sterile Compounding Center	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution recalled	Edge Pharma	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	EPINEPHrine, 2 mg per (8 mcg per mL) recalled by SterRx	SterRx	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg recalled by SterRx	SterRx	Sterility	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 Auto-Injectors in all strengths recalledEpipen	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
24 Mar 2021Drug	CLASS III	Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution recalled	Edge Pharma	Other	PA
13 May 2020Drug	CLASS II	Epinephrine Injection USP, 0.3 mg (Auto-Injector) recalledEpinephrine	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	NJ
25 Jul 2018Drug	CLASS II	EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) Volume recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
2 Aug 2017Drug	CLASS II	EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide

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.