Quick answers
- What is Epinephrine used for?
- The FDA-approved label (Epipen, Asclemed USA, Inc., August 29, 2023) says: “EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Epinephrine have a boxed warning?
- No. None of the 82 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Epinephrine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Epinephrine been recalled?
- FDA enforcement reports list 16 recalls of products of this medicine; the newest started August 11, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Epinephrine?
- 29 companies list prescription products of Epinephrine in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Medical Purchasing Solutions, LLC and Sportpharm LLC.
What Epinephrine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or …
— FDA label: Epipen, Asclemed USA, Inc., effective August 29, 2023. Read the full label on DailyMed →
The FDA has 82 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 82 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution · Injection, solution, concentrate · Spray |
|---|---|
| Route | Intramuscular · Subcutaneous · Intravenous · Intraocular · Nasal |
| Prescription products | 113 in the FDA NDC Directory |
| Brand names | Auvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride), Neffy, Epipen, Adrenalin Vials, Epinephrine Pediatrics, Epipen Jr |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| epinephrine 0.1 mg/0.1 mL injection, solution | Brand: Auvi-Q | $309.55 per unit |
| epinephrine 0.1 mg/mL injection | Generic | $1.28 per mL |
| epinephrine 0.15 mg/0.15 mL injection | Generic | $119.35 per unit |
| epinephrine 0.15 mg/0.15 mL injection, solution | Brand: Auvi-Q | $309.85 per unit |
| epinephrine 0.15 mg/0.3 mL injection | Generic | $130.36–$142.34 per unit 2 packages, lowest to highest |
| epinephrine 0.3 mg/0.3 mL injection | Generic | $112.37–$141.79 per unit 4 packages, lowest to highest |
| epinephrine 0.3 mg/0.3 mL injection, solution | Brand: Auvi-Q | $309.38 per unit |
| epinephrine 1 mg/100 uL spray | Brand: Neffy | $359.25 per unit |
| epinephrine 2 mg/100 uL spray | Brand: Neffy | $359.57 per unit |
NADAC list of November 4, 2026; these prices took effect between July 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- HF Acquisition Co LLC, DBA HealthFirst16 products
- Medical Purchasing Solutions, LLC12 products
- Sportpharm LLC9 products
- Par Health USA, LLC9 products
- BPI Labs LLC6 products
- Remedyrepack Inc.6 products
- Asclemed USA, Inc.5 products
- A-S Medication Solutions5 products
- Sina Health Inc5 products
- Gland Pharma Limited5 products
- Viatris Specialty LLC4 products
- ProPharma Distribution3 products
- Henry Schein, Inc.3 products
- kaleo, Inc3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- American Regent, Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Baxter Healthcare Corporation2 products
- Teva Pharmaceuticals USA, Inc.2 products
- ARS Pharmaceuticals Operations, Inc.2 products
- International Medication Systems, Limited2 products
- Redpharm Drug1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Civica, Inc.1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Bryant Ranch Prepack1 product
- Amneal Pharmaceuticals Private Limited1 product
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019430 EPI E Z PEN JR, EPIPEN, EPIPEN E Z PEN, EPIPEN JR. | Viatris | December 22, 1987 | 34, latest March 20, 2026 2026: Manufacturing (CMC) · 2023: Labeling · 2020: Labeling |
| NDA020800 ADRENACLICK, TWINJECT | Impax | May 30, 2003 | 20, latest March 19, 2026 2026: Labeling · 2024: Labeling · 2021: Labeling |
| NDA201739 AUVI-Q | Kaleo Inc | August 10, 2012 | 10, latest April 30, 2025 2025: Labeling · 2024: Labeling · 2019: Labeling |
| NDA204200 ADRENALIN | Ph Health | December 7, 2012 | 8, latest October 19, 2026 2026: Labeling · 2023: Labeling · 2019: Efficacy |
| NDA204640 ADRENALIN | Ph Health | December 18, 2013 | 7, latest June 22, 2026 2026: Labeling · 2023: Labeling · 2021: Manufacturing (CMC) |
| NDA205029 EPINEPHRINE | Bpi Labs | July 29, 2014 | 12, latest June 30, 2025 2025: Manufacturing (CMC) · 2024: Manufacturing (CMC) · 2024: Manufacturing (CMC) |
| NDA209359 EPINEPHRINE | Hospira | November 5, 2019 | 3, latest May 13, 2025 2025: Labeling · 2022: Manufacturing (CMC) · 2022: Manufacturing (CMC) |
| NDA211363 EPINEPHRINE | Intl Medication Sys | August 15, 2022 | — |
| NDA214697 NEFFY | Ars Pharms Operation | August 9, 2024 | 4, latest March 26, 2026 2026: Labeling · 2026: Efficacy · 2025: Labeling |
| NDA215425 EPINEPHRINE | Fresenius Kabi USA | March 13, 2025 | — |
| NDA215875 ADRENALIN | Ph Health | April 21, 2023 | 1, latest October 19, 2023 2023: Labeling |
| NDA220626 EPINEPHRINE | Baxter Hlthcare Corp | March 30, 2026 | — |
Generic approvals (11)
- ANDA207568Am Regent · July 6, 2018
- ANDA090589Teva Pharms USA · August 16, 2018
- ANDA211880Intl Medication Sys · April 24, 2020
- ANDA217192Am Regent · September 6, 2024
- ANDA213708Fresenius Kabi USA · November 20, 2024
- ANDA219239Gland · February 6, 2025
- ANDA218144Gland · June 3, 2025
- ANDA217485Amneal · October 14, 2025
- ANDA218208Amneal · December 8, 2025
- ANDA220562Hikma · May 29, 2026
- ANDA220400Gland · October 26, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 11, 2026 · Class I · Ongoing · D-0865-2026
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01 — American Regent, Inc.
-
May 14, 2026 · Class III · Ongoing · D-0581-2026
Failed Impurities/Degradations Specifications
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) — Fresenius Kabi USA, LLC
-
April 1, 2026 · Class II · Ongoing · D-0483-2026
Lack of Assurance of Sterility
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 — International Medication Systems Ltd.
-
January 17, 2024 · Class II · Completed · D-0342-2024
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01 — Henry Schein Inc. and Glove Club HSI Gloves Inc.
-
March 16, 2023 · Class III · Ongoing · D-0535-2023
Labeling; Incorrect NDC number on outer carton of product.
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-1 — Focus Health Group Inc
-
April 13, 2022 · Class II · Terminated · D-1013-2022
cGMP deviations: Temperature abuse
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-102-02 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1014-2022
cGMP deviations: Temperature abuse
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1012-2022
cGMP deviations: Temperature abuse
EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-0993-2022
cGMP deviations: Temperature abuse
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1022-2022
cGMP deviations: Temperature abuse
Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01 — Mckesson Medical-Surgical Inc. Corporate Office
-
March 15, 2021 · Class II · Terminated · D-0577-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27 — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0578-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27 — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0528-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01 — Cardinal Health Inc.
-
March 5, 2020 · Class II · Terminated · D-1260-2020
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27 — Teva Pharmaceuticals USA
-
March 12, 2017 · Class I · Ongoing · D-0691-2017
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 -- — Meridian Medical Technologies a Pfizer Company
-
March 12, 2017 · Class I · Ongoing · D-0690-2017
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- AL — Meridian Medical Technologies a Pfizer Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 310132, 727316, 727347, 727373, 727386, 1305268, 1305269, 1490057, 1660014, 1660016 … (+10) |
|---|---|
| SPL set ID of the quoted label | 311af6d9-20c0-4b87-b236-4185bfa49988 |
| FDA labels (SPL) | 82 |
| FDA applications | NDA019430, NDA020800, NDA201739, NDA204200, NDA204640, NDA205029, NDA209359, NDA211363, NDA214697, NDA215425, NDA215875, NDA220626, 11 ANDA |
| Active ingredients (FDA) | EPINEPHRINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Epipen, Asclemed USA, Inc., effective August 29, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →