Agency classClass IOur severity:Critical FDA (Food)·F-1372-2014·Announced 2014-01-22

USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Risk

USPlabs is recalling OxyELITE Pro Super Thermo Powder Plus Advanced Carnitine Transport System because it contains Aegeline, which is associated with serious liver damage or 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 agency classification is FDA Class I, and the source text explicitly associates the product with serious adverse health events, including serious liver damage or acute liver failure, which meets the criteria for a Critical severity score.

Plain-English summary

USPlabs, LLC is recalling USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT in Fruit Punch flavor. The recall was initiated after the company received a 423(a) Notification of Opportunity to Initiate a Voluntary Recall letter from the FDA. The affected products are distributed in three sizes: 0.15 oz, 4.6 oz, and 5 oz.

The recall is due to the presence of Aegeline in the products, which is associated with serious adverse health events, specifically serious liver damage or acute liver failure. The source text does not specify the number of affected units, specific lot numbers, or the exact distribution dates, though the structured data indicates a worldwide distribution pattern including various international countries.

Consumers who have purchased these products should stop using them immediately. The source text does not provide specific instructions for disposal or return, but consumers should follow any additional guidance provided by the FDA or the manufacturer.

The recalled product

Product: USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz
Manufacturer: USPlabs, LLC
Category: Food — Dietary Supplement
Hazard: liver-damage
acute-liver-failure
Affected units: 645,826

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 (6)

Fruit Prunch 0.15 oz
UPC #094922417237 and UPC #094922447517
Fruit Punch 4.6 oz
UPC #094922426369
Fruit Punch 5 oz
UPC #094922447487

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

Same hazard · liver damage