About 81,000 EpiPen devices have been recalled from countries outside the U.S. over concerns they could fail to work, news reports say.

The recall by generic drugmaker Mylan NV was prompted by reports that two of the devices failed to work in emergencies, Reuters reports.

The recall affects devices distributed in Australia, New Zealand, Europe and Japan only, according to the company.

Mylan said it is working with the regulatory authorities, where appropriate, to inform them about the recall, the paper says.

The U.S. drugmaker, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the U.S., the report notes.

EpiPen is used to inject a measured dose of empinephrine (adrenaline) in emergency situations when anaphylaxis, a potentially fatal allergic reaction, occurs.