The notice issued Friday by Mylan N.V. expands upon warnings made earlier this month after two reports of the device failing.
Mylan didn't immediately respond to a question about how many devices are affected by the recall. The U.S. Food and Drug Administration says the recall covers 13 lots distributed from December 2015 through July 2016.
The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare."
The EpiPen is used to treat allergic reactions to certain food and bug bites
The products can be replaced at no charge by calling 877-650-3494 or emailing customer.servicemylan.com.
CLICK HERE for more on the products and dosages that are affected.