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Class ITerminated in FDA datasetNov 9, 2013

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…

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 serious adverse health events, namely serious liver damage or acute liver failure.

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ProductUSPlabs 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.
UPC094922395573, 094922417251, 094922417268, 094922417275, 094922426604, 094922447852, 094922447906

FDA code information

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

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 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.

Extracted codes and context

TypeCode / valueContext
UPC094922395573# 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852
UPC0949224172512 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 9
UPC094922417268# 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 09
UPC0949224172752 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 9
UPC094922426604# 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 0
UPC094922447852; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852
UPC0949224479064; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852

Recall details

Recall number
F-1370-2014
Event ID
66813
FDA status
Terminated
Initiated
Nov 9, 2013
Reported
Jan 22, 2014
Classified
Jan 15, 2014
Terminated
Oct 13, 2015
Quantity
2,166,328 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-1370-2014

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

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