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Class ITerminated in FDA datasetRecall initiated Nov 9, 2013

USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for…

Recalling firm: USPlabs, LLC

Why it was recalled

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Oct 13, 2015.

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Compare the exact product and package details with the label you have.

ProductUSPlabs 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.
UPC094922395627, 094922447869, 094922447876, 094922447883

FDA code information

3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869

Match the product, package size, and code together. A missing match does not guarantee safety.

Full FDA record and distribution details

Original product description

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.

Extracted codes and context

TypeCode / valueContext
UPC094922395627 UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
UPC094922447869PC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
UPC0949224478763 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
UPC0949224478833 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869

Original FDA recall reason

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Recall details

Recall number
F-1371-2014
Event ID
66813
FDA status
Terminated
Initiated
Nov 9, 2013
Reported
Jan 22, 2014
Classified
Jan 15, 2014
Terminated
Oct 13, 2015
Quantity
1,065,783 units
Location
Dallas, TX, United States
Initiation type
Voluntary: Firm initiated
Notification
Press Release

Where it was distributed

Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.

FDA source record · F-1371-2014

Data updated September 16, 2026. View official FDA data ↗

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