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.

Drug Recall

Official source record

Recall number: D-0690-2017
Event ID: 76789
Classification: Class I
Status: Ongoing
Recalling company: Meridian Medical Technologies a Pfizer Company
Reason for recall: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Report date: May 10, 2017
Recall initiation date: March 12, 2017
Termination date: Not terminated as of this source record
Distribution pattern: 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, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.

Drug product identifiers

Manufacturer: Viatris Specialty LLC
Brand name: EPIPEN
Generic name: EPINEPHRINE
Substance name: EPINEPHRINE
Product NDCs: 49502-500; 49502-501
Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92
Route: INTRAMUSCULAR

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Retrieved by Public Health Trace: July 28, 2026 ET

Frequently asked questions

What does a Class I mean?

FDA classifies this recall as Class I. See how to read an FDA recall record for what each classification level means.

Is this recall still active?

According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

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Official guidance and record verification

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Compare the medication name, manufacturer, NDC, package information, and lot number on your medication with the official FDA record to see whether it matches.

Public Health Trace last retrieved this record on July 28, 2026.

Public Health Trace republishes FDA's drug recall record and does not provide medical or medication instructions -- review the official FDA record and FDA's general drug recall guidance (linked below) for what to do.

View the official FDA record · General drug recall guidance from FDA

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.