USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
USPlabs, LLC 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 recall is associated with 'serious liver damage or acute liver failure,' which meets the rubric criteria for Critical severity involving serious injury reports.
Plain-English summary
USPlabs, LLC is voluntarily recalling OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT, Grape Bubblegum flavor, Net Wt. 4.6 oz (130 g). The recall was initiated after the company received a Notification of Opportunity to Initiate a Voluntary Recall from the U.S. Food and Drug Administration.
The recall is associated with serious adverse health events, specifically serious liver damage or acute liver failure. The products contain the ingredient Aegeline. The recall covers 10,306 units with UPC #094922447500.
Distribution was worldwide, including international sales to Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220)
- Manufacturer
- USPlabs, LLC
- Category
- Food — Dietary Supplement
- Affected units
- 10,306
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 #094922447500
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
Same manufacturer · USPlabs, LLC
See all →- CriticalUSPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Risk
FDA (Food) · 2014-01-22
- CriticalUSPlabs Recalls OxyELITE Pro Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22
- CriticalUSPlabs Recalls OxyELITE Pro Super Thermo Due to Liver Damage Risk
FDA (Food) · 2014-01-22
- CriticalUSPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22
- CriticalUSPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
FDA (Food) · 2014-01-22
Same hazard · liver damage
See all →- SevereTablo Hemodialysis System recalled for PCB contamination in tubing
FDA (Devices) · 2024-04-24
- CriticalUSPlabs Recalls OxyELITE Pro Powder Linked to Liver Damage
FDA (Food) · 2014-01-22
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