Mylan Announces EpiPen and EpiPen, Jr. Voluntary Recall



EpiMylan has announced its manufacturing partner Meridian Medical Technologies expanded a voluntary recall of select lots of EpiPen® and EpiPen Jr.® epinephrine auto-injectors to the United States.

The recall is the result of two previously disclosed reports outside of the United States of the device failing due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency — such as failure to activate or an increased force needed to activate — and have significant health consequences for a patient experiencing a life-threatening allergic reaction, or anaphylaxis. 

Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare, according to Mylan, and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure.

The recalled product was distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall will also extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen auto-injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

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

Mylan will replace the recalled devices at no cost.

Here is a 4-step process for patients prescribed an EpiPen or EpiPen Jr. epinephrine auto-injector:

STEP 1: Check the lot number on your carton or device to see if your EpiPen Auto-Injector is affected by the recall.

STEP 2: If your EpiPen® Auto-Injector has been recalled, contact Stericycle at 877-650-3494 to obtain a voucher code for your free replacement product. Stericycle also will provide you with a pre-paid return package to ship the product back to Stericycle.

STEP 3: Visit your pharmacy with your voucher information to redeem your free replacement.

STEP 4: Send your recalled product to Stericycle. Do not return any devices affected by the recall until you have your replacement in hand.

Patients are advised to keep their existing EpiPen product until they obtain a replacement product. Patients should not return a recalled device until they have received a voucher to redeem their free replacement from their pharmacy.