The Recall Desk
CriticalFDA (Food)·F-1373-2014·Announced 2014-01-22

USPlabs Recalls OxyELITE Pro Powder Linked to Liver Damage

USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I and is associated with serious adverse health events, including serious liver damage and acute liver failure.

Plain-English summary

USPlabs, LLC is recalling OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT, Blue Raspberry flavor, 4.6 oz (130 g) net weight. The recall was initiated after the company received a Notification of Opportunity to Initiate a Voluntary Recall letter from the U.S. Food and Drug Administration (FDA).

The recall is associated with serious adverse health events, specifically serious liver damage or acute liver failure. The affected product contains the ingredient Aegeline. The recall covers 71,499 units with UPC #094922426376.

Distribution was worldwide, including international sales to Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina. Consumers should stop using the product and contact USPlabs, LLC for further instructions.

The recalled product

Product
USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)
Manufacturer
USPlabs, LLC
Affected units
71,499

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UPC #094922426376

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by USPlabs, LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →