HIGH RISK Terminated F-1371-2014

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.

Recalled by USPlabs, LLC

Classification

Class I — Dangerous or defective products that predictably could cause serious health problems or death.

Reason for Recall

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.

Product Details

Product Quantity

1,065,783 units

Product Type

Food

Code Info

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

Voluntary/Mandated

Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern

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.

Company Location

Dallas, TX, 75220-2445

Timeline

Report Date

01/22/2014

Recall Initiated

11/09/2013

Classification Date

01/15/2014

Termination Date

10/13/2015

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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