Updated guidelines: Download How to Manage Anaphylaxis During COVID-19

RecallEpiPen 0.3 mg and EpiPen 0.15mg auto-injectors

The FDA has issued a voluntary recall of EpiPen 0.3 mg and EpiPen 0.15mg auto-injectors and their generics manufactured by Mylan and Pfizer. This recall impacts EpiPen and the authorized generics. It does not affect other manufacturers of auto-injectable epinephrine.

The recall reports that the auto-injector device may not work, may release the drug too slow, or release the drug too early. There may also be an issue with the auto-injector device not coming out of its tube when needed.

We understand this news may worry you, but we do not recommend that you throw away the auto-injector. We ask that you please take these steps now to inspect your EpiPen, EpiPen Jr. and/or authorized generic epinephrine auto-injector:

  • Make sure that the auto-injector can easily come out of its tube
  • Check the blue safety release on top of the auto-injector; if it raised, do not push it back down
  • If the auto-injector does not easily come out of the tube OR the blue safety release is raised:
    • Do not use the auto-injector
    • Call Mylan Customer Relations 800.796.9526 to receive a replacement at no extra cost to you
    • You may also call the pharmacy where you purchased the EpiPen or epinephrine auto-injector for assistance in checking if your (your child’s) auto-injector is affected. You can find the pharmacy contact information on your (your child’s) EpiPen or epinephrine auto-injector box

If your EpiPen and/or authorized generic epinephrine auto-injector does not have any of the above listed problems, it can be used with some added precautions. It is always helpful to review your Anaphylaxis Action Plan and how to administer your specific epinephrine auto-injector.

How to use: Wrap hand tightly around EpiPen and place orange tip against outside of thigh muscle. You do not have to remove clothing. With other hand remove blue safety cap from the EpiPen. Push EpiPen firmly into thigh; you will hear a click. Hold in place while counting slowly to 3. Pull out EpiPen. A protective sheath will automatically move down to cover the needle.

Added precautions:

Do NOT use only one hand to administer an Epi-Pen.

Do NOT flip the blue safety release off using a thumb or by pulling it sideways or bending and twisting. It should only be removed by pulling straight up.

If you have any questions about this problem after calling your pharmacy, please call 617.726.8707 or send a Patient Gateway message to your provider who ordered EpiPen or authorized generic epinephrine.