Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S.

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 4/4/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***). FDA has observed foreign unapproved prescription drugs offered for sale in the United States by unsafe online pharmacies which poses a significant public health concern. Unapproved prescription drugs present serious safety and effectiveness concerns. Moreover, FDA-approved versions of these drugs are often available in the United States. Therefore, this import alert is intended to identify known distributors, including online pharmacies, of unapproved prescription drugs to U.S. consumers. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that

Quoted from the “Reason for Alert” section of the FDA page for 66-57, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.