A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

The U.S. FDA informed two pharmaceutical companies that it must update its warning labels about potential risks associated ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

U.S. cases of severe side effects from exposure to tianeptine have increased from 11 in total between 2000 and 2013 to 151 in ...

In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back ...

The letters are also valued as another form of communication from the agency, attorneys say. “Warning letters are the easiest way for us to keep an eye on enforcement trends and understand what the ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...