Supply Status Update: June 2019
Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience manufacturing challenges in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths.
These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access and will potentially continue through the summer months as seasonal demand increases.
On June 5, 2019, the U.S. Food and Drug Administration announced the extension of the expiration dates by four months of all lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S.
This announcement is based on a careful review of product stability data provided by Pfizer. Our hope is that the expiration extension will help alleviate the shortage situation as Pfizer continues its efforts to increase production and stabilize pharmacy inventories.
The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in the Impacted Product section below and can also be found on FDA’s website. The extension of the expiration dates does not apply to EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients must continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.
Locating Your Expiration Date
U.S. EpiPen Supply Frequently Asked Questions (FAQ)