After receiving 23 reports of serious health problems—indicating a possible link to liver damage—FDA has warned consumers to stop using 14 Hydroxycut products from Iovate Health Sciences Inc., Oakville, Ontario, Canada.

The company has agreed to recall products from the market after FDA received reports of health problems that ranged from jaundice to liver damage severe enough to require transplant. One death due to liver failure has been reported to FDA. Other health problems include seizures, cardiovascular disorders and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products, which contain a variety of ingredients and herbal extracts.

More than 9 million units of the Hodroxycut brand were sold in 2008. Hydroxycut products are dietary supplements marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

While FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, the list of recalled products currently includes the following:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid CapletsHydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk,” said Linda Katz, MD, interim chief medical officer of FDA’s Center for Food Safety and Applied Nutrition. “Adverse events are rare, but exist. Consumers should consult a physician or other healthcare professional if they are experiencing symptoms possibly associated with these products.”

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., commended FDA for its actions. “The potential safety problem was discovered by an adverse event reporting (AER) system that gives FDA the ability to monitor for signals or patterns of adverse events that could identify potential safety problems,” he said. “It should be noted that adverse events do not establish causality, nor is enough known at this point to determine whether the adverse events associated with these products were idiosyncratic, dose-related, ingredient-related or simply random. CRN believes FDA took appropriate action to protect consumers, while not drawing speculative conclusions until further investigation is completed.”