CVM’s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs.

“The manufacturer of carbadox has failed to provide sufficient scientific data to demonstrate the safety of this drug given evidence that carbadox may result in carcinogenic residues,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine.

“As a result, FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the marketplace.”

The FDA is not recommending that people make changes in their food choices while the agency is working to remove carbadox from the market. Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues, and short-term changes in diet are unlikely to affect a person's lifetime risk. However, removal of the product from the market will reduce the lifetime risk to consumers, which is why CVM is taking this action. Pork liver is used to make liverwurst, hot dogs, lunchmeat and some types of sausage. In general, eating a varied diet may reduce the potential negative effects of eating too much of any one food.

FDA-approved alternative antibiotics are available to pork producers to treat swine.

CVM is committed to working with pork producers to minimize impacts on the swine industry.