Agency classClass IOur severity:Critical FDA (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.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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: liver-damage
liver-failure
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 →

Same manufacturer · USPlabs, LLC

See all →

Critical
USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Risk
FDA (Food) · 2014-01-22
Critical
USPlabs Recalls OxyELITE Pro Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22
Critical
USPlabs Recalls OxyELITE Pro Super Thermo Due to Liver Damage Risk
FDA (Food) · 2014-01-22
Critical
USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22
Critical
USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22

Same hazard · liver damage