The Food and Drug Administration says USPlabs of Dallas is recalling OxyElite Pro products thought to have impurities. The dietary supplement is used for weight loss and muscle-building.
After linking the products to dozens of hepatitis and liver failure cases in Hawaii, investigators linked the pills to cases in a number of other states, too.
The FDA says one of the patients died, another needed a liver transplant and others are now awaiting liver transplants.
The recall followed a letter from the FDA notifying USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order an immediate halt to distribution of the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act.