Information for Patients: Epi-Pen Recall

The Epi-Pen recall was initiated after an initial, previous recall of Epi-Pens in Europe and Australia related to two incidents were identified as a device delivery malfunction, seemingly isolated to a small mechanical piece in the body of the device. No similar issues have arisen in U.S. distributed devices and there was no patient injury as a result.

A voluntary recall of 10 percent of the devices in the U.S. from lots distributed between December 2015 and July 2016 was initiated according to an Epi-Pen representative for the purpose of testing to identify if a similar problem exists.

The procedure for the patient is to:

  1. Check the Lot Number on the box and see if the Epi-Pen corresponds with a U.S. Impacted Lot
  2. If the Lot Number does correspond, the patient will need to call Stericycle at 877-650-3494
  3. Stericycle will provide the patient with a replacement voucher code
  4. Patients with corresponding, recalled Epi-Pens will then go to their pharmacy to get a replacement Epi-Pen
  5. Stericycle will send the patient a package that they can use to send the original, recalled device/devices to Mylan for testing

Information sheets will be available in Allergy Associates offices with additional information

Stericycle Phone: 877-650-3494

U.S. Impacted Lots:

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

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

Press Release for Inquiries

Back to Top