Mylan Recalls U.S. EpiPens Following International Recall of 81,000 EpiPens

Mylan is voluntarily recalling 13 of its U.S. EpiPen and EpiPen Jr. products after an international recall of approximately 81,000 EpiPens.

This recall comes after two reports that EpiPens distributed outside of the U.S., failed to activate due to a potential defect in the pen portion of the device. “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),” Mylan said in a statement.

The EpiPens affected by the recall were distributed by Mylan between December 2015 and July 2016. If you have one of the following products, return it to Mylan:

Product/Dosage	NDC Number	Lot Number	Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg	49502-501-02	5GN767	April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg	49502-501-02	5GN773	April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg Advertisement	49502-500-02	5GM631	April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	5GM640	May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg	49502-501-02	6GN215	September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM082	September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM072	September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM081	September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM088	October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM199	October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM091	October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM198	October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg	49502-500-02	6GM087	October 2017

Mylan says it will accept all recalled EpiPens and will replace them with a comparable product free of charge.

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Mylan Recalls U.S. EpiPens Following International Recall of 81,000 EpiPens