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.
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 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
- 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 →Related recalls
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