Agency classClass IOur severity:Critical FDA (Food)·F-1370-2014·Announced 2014-01-22

USPlabs Recalls OxyELITE Pro Super Thermo Due to Liver Damage Risk

USPlabs is recalling OxyELITE Pro Super Thermo 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 involves serious adverse health events, including serious liver damage and acute liver failure, which meets the criteria for a Critical severity score.

Plain-English summary

USPlabs, LLC is recalling OxyELITE Pro Super Thermo dietary supplements after receiving a notification from the U.S. Food and Drug Administration (FDA) to initiate a voluntary recall. The recall involves products containing the ingredient Aegeline, which is associated with serious adverse health events, specifically serious liver damage or acute liver failure.

The recalled products are distributed in various capsule sizes, including 2, 10, 21, 90, and 180 count bottles. The company has distributed approximately 2.16 million units worldwide, including in international markets such as Ecuador, Russia, the UAE, and China.

Consumers who have purchased these products should stop using them immediately. The FDA advises that the presence of Aegeline in these supplements poses a significant risk of severe liver injury.

The recalled product

Product: USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.
Manufacturer: USPlabs, LLC
Category: Food — Dietary Supplement
Hazard: liver-damage
acute-liver-failure
aegeline
Affected units: 2,166,328

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 (13)

2 count capsules
UPC # 094922417275
10 count capsules
UPC # 094922417251
UPC # 094922417268
21 count capsules
UPC # 094922426604
90 count capsules
UPC # 094922395573
90 count capsules "Pink Label"
UPC # 094922447906
180 count capsules
UPC # 094922447852

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 →

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

Same hazard · liver damage