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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

    Locating Your Expiration Date1

    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 Viatris Customer Relations at 800.796.9526.

    Locating Your Expiration Date2

  • 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

Need Help?

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

INDICATIONS (the following information applies to both Epipen and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN of EPIPEN JR.

IMPORTANT SAFETY INFORMATION (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® (epinephrine injection, USP) 0.3 mg and EPIPEN JR® (epinephrine injection, USP) 0.15 mg Auto-Injectors are used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

Always carry 2 EPIPEN or 2 EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

When you have an allergic emergency (anaphylaxis), use EPIPEN or EPIPEN JR auto-injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR auto-injector. You can use a second EPIPEN or EPIPEN JR auto-injector if symptoms continue or if the first auto-injector is activated. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

Before you use EPIPEN or EPIPEN JR auto-injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson’s disease, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider about all of your known allergies. 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 your EPIPEN or EPIPEN JR auto-injector.

Especially tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work. Other medicines my affect how EPIPEN and EPIPEN JR auto-injector works.

EPIPEN or EPIPEN JR auto-injector should 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. It is very important that you hold the EPIPEN or EPIPEN JR auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the EPIPEN or EPIPEN JR auto-injector might not have time to deliver the correct dose of medicine. If you accidentally inject EPIPEN or EPIPEN JR auto-injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away. If you inject a young child, hold their leg firmly in place before and during the 3 second injection to prevent injuries.

Rarely, patients who have used EPIPEN or EPIPEN JR auto-injectors may get infections 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.

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 may go away with rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.


 Please see the full Prescribing Information and Patient Information for EPIPEN.

Please see the full Prescribing Information and Patient Information for the Authorized Generic for EPIPEN.

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.

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INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN of EPIPEN JR.

INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN of EPIPEN JR.

IMPORTANT SAFETY INFORMATION (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® (epinephrine injection, USP) 0.3 mg and EPIPEN JR® (epinephrine injection, USP) 0.15 mg Auto-Injectors are used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

Always carry 2 EPIPEN or 2 EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

When you have an allergic emergency (anaphylaxis), use EPIPEN or EPIPEN JR auto-injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR auto-injector. You can use a second EPIPEN or EPIPEN JR auto-injector if symptoms continue or if the first auto-injector is activated. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

Before you use EPIPEN or EPIPEN JR auto-injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson’s disease, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider about all of your known allergies. 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 your EPIPEN or EPIPEN JR auto-injector.

Especially tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work. Other medicines my affect how EPIPEN and EPIPEN JR auto-injector works.

EPIPEN or EPIPEN JR auto-injector should 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. It is very important that you hold the EPIPEN or EPIPEN JR auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the EPIPEN or EPIPEN JR auto-injector might not have time to deliver the correct dose of medicine. If you accidentally inject EPIPEN or EPIPEN JR auto-injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away. If you inject a young child, hold their leg firmly in place before and during the 3 second injection to prevent injuries.

Rarely, patients who have used EPIPEN or EPIPEN JR auto-injectors may get infections 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.

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 may go away with rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.


 Please see the full Prescribing Information and Patient Information for EPIPEN.

Please see the full Prescribing Information and Patient Information for the Authorized Generic for EPIPEN.

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.

  • About EPIPEN and the Authorized Generic for EPIPEN
  • What Is Anaphylaxis?
  • Have a Plan
  • Access to EPIPEN and the Authorized Generic to EPIPEN
  • About EPIPEN and the Authorized Generic for EPIPEN
  • What Is Anaphylaxis?
  • Have a Plan
  • Access to EPIPEN and the Authorized Generic to EPIPEN
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