The expanded voluntary recall is being initiated in the USA and also will extend to additional markets in Europe, Asia, North and South America.
They say there haven't been any confirmed cases involving lots of the injectors distributed in Canada.
This particular lot was not distributed in the U.S. The recall was initiated after Mylan received two confirmed reports of the devices failing to activate due to a possible defect.
The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare".
EpiPen Jr (0.15 mg epinephrine) auto-injector lot 5GR765, expiry date March 2017. According to the statement released by Mylan, the recalled products will be replaced at no extra cost to customers.
The recall notice also advises patients to carry their recalled EpiPen until they receive a replacement.
Consumers with questions regarding this recall can contact Pfizer Medical Information at 1-800-463-6001 between 9:00 a.m. and 5:00 p.m. EST.
EpiPens administer doses of epinephrine to patients with anaphylaxis - a serious allergic reaction that can be fatal if not treated immediately.
If you have a recalled EpiPen, the FDA says don't toss it out until you get a replacement.