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[11/2/2018] FDA is alerting patient s, caregivers and Health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injector s, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. In a letter to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube. The auto-injector device and the epinephrine it delivers are not affected by this issue and c...

Update [4/9/2020] FDA is notifying patients and caregivers that EpiPens are not being recalled at this time. We urge patients and caregivers to use the EpiPens they have on hand and be aware of the potential issues outlined in the statement below. [3/24/2020]  FDA is alerting patient s, caregivers and Health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injector s, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to: Device failure from spontaneous activation caused by using sideways force to remove the blue safety release Device failure from inadvertent or spontaneous activation due to a raised blue safety release Difficulty removing the device from the carrier tube User errors In a letter to health care professional...

[6/1/2020]  FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. In letters to Health care professionals and consumers, Impax Laboratories LLC, a subsidiary of Amneal Pharmaceuticals LLC, the manufacturer of the epinephrine auto-injector , detailed how certain lots of these device s might not contain the yellow “stop collar” component. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient . It is vital for lifesaving products to work as designed in an emergency situation. Patients, pharmacists and Health care professionals who have receive...