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

Published On 2017-04-02 06:19 GMT   |   Update On 2017-04-02 06:19 GMT

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.


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 customer.service@mylan.com 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.


























































































Product/DosageNDC NumberLot NumberExpiration Date
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN767April 2017
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN773April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM631April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM640April 2017
EpiPen Jr Auto-Injector, 0.15 mg49502-501-026GN215September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM082September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM072September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM081September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM088October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM199October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM091October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM198October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM087October 2017

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.

Article Source : FDA

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