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.

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/Dosage          NDC Number  Lot Number     Expiration Date

EpiPen Jr Auto-Injector, 0.15 mg        49502-501-02 5GN767           Apr-17

EpiPen Jr Auto-Injector, 0.15 mg        49502-501-02 5GN773           Apr-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631          Apr-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640          Apr-17

EpiPen Jr Auto-Injector, 0.15 mg        49502-501-02 6GN215           Sep-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082          Sep-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072          Sep-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081          Sep-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088          Oct-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199          Oct-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091          Oct-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198          Oct-17

EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087          Oct-17

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.