USPLabs of Dallas is recalling specific OxyElite Pro dietary supplements in response to a letter from the FDA stating the products were linked to dozens of cases of acute liver failure, nonviral hepatitis and at least one death, the FDA reported.
“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and nonviral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention,” Daniel Fabricant, PhD, director of the FDA’s Division of Dietary Supplement Programs, said in a news release.
As of the end of August, 56 cases of acute liver failure or acute hepatitis were linked to OxyElite Pro, including 43 cases in Hawaii. Several patients required liver transplants, the release said.
Earlier this year, the administration warned the company that certain OxyElite Pro products advertised for weight loss and muscle building were considered adulterated because they contained dimethylamylamine, a stimulant that can cause high blood pressure and can lead to heart attacks, seizures, psychiatric disorders and death, the release said. These products were destroyed, but the company substituted aegeline, among other ingredients, in certain OxyElite Pro products.
In October, the FDA advised USPLabs these OxyElite Pro and VERSA-1 products were considered adulterated because the company had failed to provide evidence of safety of aegeline.
“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” Fabricant said. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
The FDA will oversee USPLabs’ destruction of warehouse stocks of the supplement with a retail value of about $22 million. The FDA advises consumers not to use dietary supplements labeled OxyElite Pro or VERSA-1.
Recalled products include:
OxyElite Pro Super Thermo capsules
- 2-count capsules, UPC #094922417275
- 10-count capsules, UPC #094922417251
- 10-count capsules, UPC #094922417268
- 21-count capsules, UPC #094922426604
- 90-count capsules, UPC #094922395573
- 90-count capsules “Pink label,” UPC #094922447906
- 180-count capsules, UPC #094922447852
OxyElite Pro Ultra-Intense Thermo capsules
- 3-count capsules, UPC #094922447883
- 3-count capsules, UPC #094922447876
- 90-count capsules, UPC #094922395627
- 180-count capsules, UPC #094922447869
OxyElite Pro Super Thermo Powder
- Fruit Punch 0.15 oz, UPC #094922417237
- Fruit Punch 0.15 oz, UPC #094922447517
- Fruit Punch 4.6 oz, UPC #094922426369
- Fruit Punch 5 oz., UPC #094922447487
- Blue Raspberry 4.6 oz, UPC #094922426376
- Grape Bubblegum 4.6 oz, UPC #094922447500
- Green Apple 4.6 oz., UPC #094922426499
- Raspberry Lemonade 4.6 oz. UPC #094922447494