If you think you may be impacted by this recall, please follow these steps:
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.
Stericycle’s hours of operation are Monday-Friday 8:00 am - 10:00 pm, and Saturday and Sunday 8:00 am - 5:00 pm.
Replacement and Return InstructionsRecalled Lots in U.S.
IMPORTANT NOTE: The NDC on the box ends with “2” because it contains two EpiPen Auto-injectors. The NDC on the individual EpiPen within the box has an NDC ending in “1."
Confirmation of recalled product
You can confirm if you are in possession of a recalled EpiPen product by checking if the lot number matches any of the lot numbers listed in the above table.
On the auto-injector, the lot number is located at the top of the label in black and preceded by the word ‘LOT.’
On the carton, the lot number is located on the left flap, which is black in color. You will find the lot number written in white and preceded by the word ‘LOT.’If your EpiPen® Auto-Injector has been recalled, contact Stericycle at 877-650-3494 to obtain a voucher code for your free replacement product. If not, there is no further action necessary.
Product Replacement Voucher Program
Stericycle will provide you with a voucher code to redeem a free replacement product. If you called before Monday, April 3, Stericycle will follow-up with your voucher code via phone or email beginning Tuesday, April 4.
Each voucher is valid for one EpiPen 2-Pak or EpiPen Jr 2-Pak, or one of Mylan’s authorized generic for EpiPen 2-Pak or EpiPen Jr 2-Pak. Stericycle will issue one voucher for every two-pack that needs to be replaced. Each two-pack carton contains two auto-injectors.
After you have received your voucher, follow these steps:
STEP 1: Call your pharmacy to inform them that you have a voucher for your free replacement of the product.
STEP 2: Confirm with your pharmacy that you have a fillable prescription for EpiPen or Mylan’s authorized generic for EpiPen on file.
STEP 3: Confirm that the pharmacy has the medication in stock.
Patients may receive either EpiPen Auto-Injector or Mylan’s authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto-Injector, and may be substituted for EpiPen Auto-Injector.
Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall.
Product Return Process
If you are in possession of a recalled product, call Stericycle at 877-650-3494 to provide you with a pre-paid return package to ship the product back to Stericycle.
IMPORTANT: Do not return any devices affected by the recall until you have redeemed your free replacement from your pharmacy and have your replacement in hand.