FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or [email protected] with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA's MedWatch program, by:

• Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or  
• Downloading and completing the form, then submitting it via fax at 800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Theresa Eisenman, 301-796-2969, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Related Links

http://www.fda.gov