While the EpiPen has undoubtedly saved a number of lives, an EpiPen recall caused by flawed manufacturing has now placed the people who depend on it in danger.

An EpiPen recall of 80,000 pens was initiated across Australia and New Zealand, with a press release from the parent company, Mylan, stating: “The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life-threatening.”

The U.S. Food and Drug Administration (FDA) cited “significant violations of good manufacturing practice” in a letter addressed to the manufacturer Meridian Medical Technologies, a unit of Pfizer.

The EpiPen, a pen-shaped device created to administer epinephrine for prevention of severe allergic reactions, was FDA-approved in 1987, after its initial use treating military personnel in the event of chemical warfare.

Just last month, a $465 million settlement between Mylan and the U.S. Department of Justice was finalized over claims that the federal government was overcharged for the product. Mylan increased the price of two EpiPen injectors to $600 last year, which played a part in sparking pharmaceutical pricing debates during discussions about the 21st Century Cures Act. The company responded to the subsequent backlash by releasing Adrenaclick, a generic version at half the cost.

Mylan has also been criticized for the EpiPen’s 26-part design and brief 18-month shelf life. The highly sensitive chemical makeup of epinephrine is such that it cannot be exposed to air or light, hence the elaborate housing.

But a recent study conducted by the California Poison Control System evaluated nearly 40 unused, expired pens and found that all of the devices contained over 80 percent of their initial epinephrine dose, enough for adequate treatment of anaphylaxis.

The study also concluded that expired EpiPens still maintain some efficacy up to four years past its advertised expiration date. Replacing expired pens is still recommended by doctors, and there is talk the expiration date for EpiPens could be extended.