Update | March 2017

Epi Pen Recall

EpiPen® and EpiPen Jr® Auto-Injector, 0.3 mg and 0.15 mg strengths

On March 31, 2017, Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen Auto-Injector, expanded its voluntary recall of certain lots of EpiPen® and EpiPen Jr® Auto-Injector. The recall now includes products marketed in the United States, Europe, Asia, North and South America. This recall is being done with the help of the U.S. Food and Drug Administration (FDA).

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector manufactured and distributed between December 2015 and July 2016. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

Here are the U.S. lot numbers impacted by this recall:

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr 2 Pak® Auto Injectors, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr 2 Pak® Auto Injectors, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr 2 Pak® Auto Injectors, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen 2 Pak® Auto Injectors, 0.3 mg 49502-500-02 6GM087 October 2017

Why are these products being recalled?

There were two reports outside the U.S. of EpiPen not working due to a possible defect with the device.* This defect may make EpiPen hard to use during a life-threatening allergic reaction. Both reports are related to a single lot previously recalled. So far, no other devices have been found to have an issue. For everyone's safety, the recall was expanded to include more lots.

What is EpiPen® and EpiPen Jr® Auto-Injector?

EpiPen and EpiPen Jr are brand medications used to treat severe allergic reactions. During an allergic reaction, the epinephrine in EpiPen constricts blood vessels to increase blood pressure, relaxes smooth muscles in the lungs to reduce wheezing and improve breathing, stimulates the heart (increases heart rate) and works to reduce hives and swelling that may occur around the face and lips. EpiPen comes in a two-pack carton and contains a trainer pen.

What should you do next?

Check the lot number of your EpiPen. It's located in a black label on both the box and device. You'll see "LOT" and then a series of numbers. That's the lot number. If your lot number matches what's on the list, your EpiPen was recalled. If your lot number doesn't match what's on the list, your EpiPen wasn't recalled.

You can also call Stericycle to find out if your device was recalled. Stericycle is a company that provides medical waste removal services. They can be reached at 1 (877) 650-3494 (Monday through Friday 8:00 a.m. to 5:00 p.m. ET and Saturday through Sunday 8:00 a.m. to 5:00 p.m. ET). They'll help you return and replace your EpiPen at no cost.

Questions or concerns?

For more information about this recall or to find out how you can return and replace your EpiPen device:

  • Call Stericycle at 1 (877) 650-3494 (Monday through Friday 8:00 a.m. to 5:00 p.m. ET and Saturday through Sunday 8:00 a.m. to 5:00 p.m. ET).
  • Go to Mylan.com/EpiPenRecall
  • Call Mylan Customer Relations at 1 (800) 796-9526 or customer.service@mylan.com.

 

If you have questions about your health, you should talk to your doctor. If you're a Cigna customer and have questions, please call Customer Service using the number on your ID card. We're here to help.

* From the U.S. Food and Drug Administration (FDA) website and Mylan's press release. Retrieved 04/03/17.