November 10, 2013 — USPLabs, LLC and the U.S. Food and Drug Administration (FDA) have announced an OxyElite Pro recall. The recall for OxyElite Pro followed an FDA warning letter linking the products to liver injuries. The FDA has also warned that there is a “reasonable probability” that the products are adulterated, and therefore illegal to sell.
USPLabs has delayed issuing the recall for months while continuing to defend the safety of their product. The Hawaii Department of Health first identified liver injuries from OxyElite Pro in September 2013, and warned that illnesses dated back to at least May.
The FDA finally threatened to force USPLabs to issue a recall if they did not recall OxyElite Pro voluntarily. It is the second time the FDA has exercised such authority under the Food Safety Modernization Act (FSMA), passed in 2011.
The FDA sent USPLabs a Warning Letter on October 11 after finding a possible “causal connection” between OxyElite Pro and liver injuries. They also found that OxyElite Pro contained aegeline, an unapproved ingredient.
The FDA reviewed medical records on 46 people with liver damage, including 27 (58%) who took OxyElite Pro. Seventeen out of 27 (63%) reported that OxyElite Pro was the only supplement they were taking. One patient died, one has had a liver transplant, and others are on a waiting list for a liver transplant.
Products included in the OxyElite Pro recall:
- OxyElite Pro Super Thermo capsules
- two 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
- three count capsules UPC #094922447883
- three 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
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