The Recall Desk
CriticalFDA (Food)·F-1376-2014·Announced 2014-01-22

USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

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 source text explicitly states the product is associated with 'serious liver damage or acute liver failure,' which meets the rubric criteria for a score of 5 due to reports of serious injury.

Plain-English summary

USPlabs, LLC is recalling OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT, Net Wt. 4.6 oz (130 g), Raspberry Lemonade flavor. The recall involves 10,278 units with UPC #094922447494. The product was distributed worldwide, including in Ecuador, Russia, the UAE, South America, the Dominican Republic, Kuwait, the Philippines, Indonesia, Egypt, Panama, China, and Argentina.

The recall was initiated after USPlabs received a Notification of Opportunity to Initiate a Voluntary Recall letter from the FDA. The agency identified the product as containing Aegeline, an ingredient associated with serious adverse health events, specifically serious liver damage or acute liver failure.

Consumers who have purchased this product should stop using it immediately. The source text does not provide specific instructions for disposal or refund procedures, but consumers should contact the recalling firm or the FDA for further guidance.

The recalled product

Product
USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) RASPBERRY LEMONADE Manufactured for USPlabs, LLC (Dallas, TX 75220)
Manufacturer
USPlabs, LLC
Category
Food — Dietary Supplement
Hazard
Affected units
10,278

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 #094922447494

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 →

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