FDA Extends Expiration Date on Select EpiPen Lots
August 21, 2018 – The U.S. FDA has announced that it is extending the expiration date on certain lots of Mylan’s EpiPen® (epinephrine auto-injector) 0.3mg in an effort to address product shortages. Following review, the FDA elected to push back the expiration date by four months on the chosen lots.
Demand for the EpiPen and similar products historically increases at the beginning of the school year in the United States. The FDA hopes to help meet that demand with this latest tactic to improve EpiPen availability. Ordinarily, EpiPens are approved for a 20-month shelf life. However, the FDA has determined that the chosen lots can be granted an extended shelf life of 24 months. To ensure safety and efficacy, the products must be properly stored, as detailed in the product labeling.
A list of lots selected for the four-month extension can be found at:
The FDA will not require these products be relabeled with the new expiration dates, and expects them to be replaced and properly disposed of if new product becomes available.