The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-1371-2014·Announced 2014-01-22

USPlabs Recalls OxyELITE Pro Due to Serious Liver Damage Reports

USPlabs is recalling OxyELITE Pro dietary supplements 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 recall is classified as FDA Class I and is associated with serious adverse health events, specifically serious liver damage or acute liver failure, which meets the criteria for a Critical severity score.

Plain-English summary

USPlabs, LLC is voluntarily recalling OxyELITE Pro Ultra-Intense Thermo Advanced Formula dietary supplements. The recall was initiated after the company received a notification from the U.S. Food and Drug Administration (FDA) regarding products containing the ingredient Aegeline.

The FDA identified the recall as Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences. The specific health events associated with the product include serious liver damage or acute liver failure.

The recalled products were distributed worldwide, including in the United States and international markets such as Ecuador, Russia, the UAE, South America, the Dominican Republic, Kuwait, the Philippines, Indonesia, Egypt, Panama, China, and Argentina. The affected products are sold in 3-count, 90-count, and 180-count capsule sizes. Consumers should stop using the product and contact USPlabs for further instructions.

The recalled product

Product
USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.
Manufacturer
USPlabs, LLC
Category
Food — Dietary Supplement
Hazard
Affected units
1,065,783

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)

  • 3 count capsules
  • UPC #094922447883
  • 3 count capsules UPC #094922447876
  • 90 count capsules
  • UPC #094922395627
  • 180 count capsules UPC #094922447869

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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