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# FDA Bans Drugs with Isometheptene
- URL: https://www.fdaweb.com/fda-bans-drugs-with-isometheptene/
- Published: 2018-06-14T12:00:00.000Z
- Updated: 2026-09-15T00:13:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141682

FDA says the manufacturers and labelers of 11 drug products that contain isometheptene agreed to comply with a 10/12/17 agency order to stop distributing their isometheptene mucate-containing drug products as of 1/1/18\. An agency [notice](https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm609279.htm?ref=fdaweb.com) says the affected products contain either isometheptene mucate, discloralphenazone, and acetaminophen, or isometheptene mucate, caffeine, and acetaminophen.

“FDA considers isometheptene-containing drug products unapproved new drugs that cannot be distributed in interstate commerce without an NDA approved by FDA,” the notice says.