Quick answers
- What is Epipen?
- Epipen is a brand name of Epinephrine, a prescription medicine. The FDA NDC Directory lists 2 Epipen products in 1 strength and form.
- Who makes Epipen?
- Viatris holds the FDA application for Epipen (NDA019430, approved December 22, 1987). 1 other company (repackagers or distributors) also list Epipen products.
- Is there a generic or store brand of Epipen?
- Yes. The FDA NDC Directory lists 20 other products with the same active ingredients, strength and form as a Epipen product, 19 of them generic. Ask your pharmacist whether one is right for you.
- Has Epipen been recalled?
- FDA enforcement reports list 5 recalls of Epipen products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Epipen is
Each Epipen product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Epinephrine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| epinephrine 0.3 mg/0.3 mL injection (intramuscular) | Epipen | 20 products, 12 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Epinephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019430 | Viatris | December 22, 1987 | 2 |
Companies that list Epipen
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Epipen products.
- Viatris Specialty LLC1 product
- Asclemed USA, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
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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
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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.
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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
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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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.