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USPlabs, LLC
FDA recall F-1370-2014 · Class I · reported 2014-01-22 · Terminated
- Product
- 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.
- 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.
- Quantity
- 2,166,328 units
- Distribution
- 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.
- Firm location
- TX, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Press Release
- Recall started
- 2013-11-09
- Terminated
- 2015-10-13
- Code info
- 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
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.