Consumers should contact Mylan at 800-796-9526 or firstname.lastname@example.org with any questions. Meridian Medical Technologies manufactured the devices, which were distributed by Mylan Specialty, the FDA said.
EpiPens not included in the recall do not need to be replaced before their expiration dates, the FDA said.
Amid accusations of price gouging, Mylan CEO Heather Bresch testified before Congress in September. And in October, the company agreed to pay the US government $465 million after it was accused of falsely classifying the EpiPen to overcharge the Medicaid system.
In response, Mylan started offering $300 savings cards for patients who have to pay full price and began developing its generic spinoff.
About 15 million people have food allergies in the U.S., and allergic reactions account for about 200,000 emergency room visits per year, according to Food Allergy Research & Education.