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  1. Report a Problem to the FDA

When and Where to Report Emergencies


Red circle with words Call 911 Emergency


If you are currently experiencing a medical emergency, please call 911.





For emergencies involving FDA regulated products

Call FDA's emergency number: 1-866-300-4374 or 301-796-8240. It is staffed 24 hours a day, seven days a week


Examples of when to Call FDA’s emergency number:

  • You are a medical professional requesting approval for the use of an emergency investigational new drug or biologic

  • When a government agent acting in an official capacity needs to notify FDA about an urgent matter
  • To report an emergency involving an FDA employee or an FDA employee's family member
  • You or someone you are with is currently having a non-life threatening adverse reaction to an FDA-regulated product that requires immediate reporting

For Non-Emergencies visit How to Report a Non-Emergency




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