Expiration Extension

On June 5, 2019, the U.S. Food and Drug Administration announced the extension of the expiration dates by four months of all lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S.

This action was based on a careful review of product stability data by Pfizer and intended to alleviate temporary supply constraints at the time of its announcement. Since then, U.S. supplies of EpiPen and its authorized generic have stabilized to normal levels to meet demand.

The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in the Impacted Product section below and can also be found on FDA’s website. The extension of the expiration dates does not apply to EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients must continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.

  • Locating Your Expiration Date

    The expiration date for EpiPen 0.3 mg Auto-Injectors and its authorized generic is located on both the carton and auto-injector itself. Please see example images.

    •  • On the auto-injector, the expiration date is located at the top of the label in black and preceded by the word ‘EXP.’
    •  • On the carton, the expiration date is located on the left flap, which is black in color. You will find the expiration date written in white and preceded by the word ‘EXP.’

    You can confirm if your auto-injector's expiration date has been extended by checking if it matches any of the expiration dates listed in the Impacted Product section below.

    If you have any questions regarding the expiration date of your auto-injector, please call Mylan Customer Relations at 800.796.9526.

  • Impacted Product

    Epinephrine Injection, USP Auto-Injectors 0.3 mg
    NDC 49502-102-02 appears on the box
    NDC 49502-102-01 appears on the individual device within the box

    EpiPen® (epinephrine Injection, USP) 0.3 mg Auto-Injectors
    NDC 49502-500-02 appears on the box
    NDC 49502-500-01 appears on the individual device within the box

    NEW EXTENDED EXPIRATION DATES

    Manufacturer's Original Expiration Date

    New Expiration Date
    Please note: Expiration dates are valid through the last day of the month listed
    Feb 19 Jun 19
    Mar 19 Jul 19
    Apr 19 Aug 19
    Jun 19 Oct 19
    Jul 19 Nov 19
    Aug 19 Dec 19
    Sep 19 Jan 20
    Oct 19 Feb 20
    Nov 19 Mar 20
    Dec 19 (only available in Epinephrine Injection 0.3 mg) Apr 20
    Jan 20 May 20
    Feb 20 (only available in Epinephrine Injection 0.3 mg) Jun 20
    Mar 20 (only available in Epinephrine Injection 0.3 mg) Jul 20
    Apr 20 Aug 20
    May 20 (only available in Epinephrine Injection 0.3 mg) Sep 20
    Jun 20 Oct 20
    Aug 20 (only available in Epinephrine Injection 0.3 mg) Dec 20
    Sept 20 Jan 21
    Oct 20 (only available in Epinephrine Injection 0.3 mg) Feb 21

Share This Site

Need Help?

If you are experiencing difficulty accessing product, please call Mylan's Customer Relations for assistance in locating other pharmacies at 800.796.9526 M-F, 8a-5p ET.

More Important Safety Information

Use EpiPen® (epinephrine injection, USP) 0.3 mg or EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EpiPen® or EpiPen Jr® should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used EpiPen® or EpiPen Jr® may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use EpiPen® or EpiPen Jr®.

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Indications

EpiPen® and EpiPen Jr®  Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.


Please see the full Prescribing Information and Patient Information.

For additional information please contact us at 800-796-9526.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

EpiPen® & EpiPen Jr® (epinephrine injection, USP) Auto-Injectors 0.3/0.15mg

You are now leaving Viatris Inc's website.

The website you are about to access is not owned or controlled by Viatris Inc.

VIATRIS INC. ASSUMES NO RESPONSIBILITY FOR, AND MAKES NO REPRESENTATION AS TO THE ACCURACY OF, ANY CONTENT CONTAINED ON THE WEBSITE YOU ARE ABOUT TO ACCESS.

OK

Prescribing Information