EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

Recall Insight

This FDA Drug action (record #D-0690-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on March 12, 2017. It is classified under Critical severity (Class I), with a current status of Ongoing. Meridian Medical Technologies a Pfizer Company is listed as the recalling firm, operating out of Brentwood, MO. Federal records indicate 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.