From the FDA: EpiPen and and EpiPen Jr Auto-Injector: Recall — Failure to Activate Device

Mylan NV announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto–Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto–Injectors to now include additional lots distributed in the US and other markets. This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the US of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life–threatening allergic reaction (anaphylaxis).

RECOMMENDATION: Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions.