USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports
USPlabs 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 FDA classified this as a Class I recall, and the source text explicitly links the product to serious adverse health events including serious liver damage and acute liver failure.
Plain-English summary
USPlabs, LLC is recalling OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT, Net Wt. 4.6 oz (130 g), Green Apple flavor. The recall was initiated after the company received a Notification of Opportunity to Initiate a Voluntary Recall letter from the U.S. Food and Drug Administration (FDA).
The product is being recalled because it contains Aegeline and is associated with serious adverse health events, specifically serious liver damage or acute liver failure. The recall covers 21,325 units of the product, identified by UPC #094922426499. Distribution was worldwide, including international sales to Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.
Consumers who have purchased this product should stop using it immediately. The source text does not specify a return process or refund policy, but the FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences.
The recalled product
- Product
- USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GREEN APPLE Manufactured for USPlabs, LLC (Dallas, TX 75220)
- Manufacturer
- USPlabs, LLC
- Category
- Food — Dietary Supplement
- Affected units
- 21,325
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 #094922426499
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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