The recalled devices may contain a defective part that could cause the pens to fail to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty, the FDA said.
The FDA said the number of reported failures is small, but the lots are being recalled because failure to activate and treat a severe allergic reaction is a life-threatening risk.
The affected lots are:
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 5GN767 Expires: April 2017
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 5GN773 Expires: April 2017
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 6GN215 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 5GM631 Expires: April 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 5GM640 Expires: May 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM082 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM072 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM081 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM088 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM199 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM091 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM198 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM087 Expires: October 2017
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