The board has charged the Iowa-licensed compounding pharmacy FarmaKeio with violating provisions of the federal Food, Drug and Cosmetics Act.

A Mahwah-based drugmaker is being sued after recalling millions of potassium chloride capsules linked to serious health risks. The FDA called it a Class I recall—the most serious kind.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters.

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

Q’Apel recalled the device in February, three weeks after the FDA sent the warning letter. The company asked customers to quarantine and return all affected systems in exchange for credit.

WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.

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

In an official filing, the company stated that it does not anticipate the warning letter will disrupt supply chains or affect ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update Wednesday, ...

The FDA, under Health Secretary Robert F. Kennedy Jr., has taken another step to question the safety of Covid-19 vaccines.