Food recall: USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in…
Class I FDA enforcement event 66813. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
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
USPlabs, LLC started this food recall on 9 Nov 2013. The firm address in the FDA record is in Dallas, TX. FDA put the recall in Class I. FDA event 66813 has 7 product records. The first FDA enforcement report date is 22 Jan 2014. The record gives the status Terminated, with the termination date 13 Oct 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines,…
Recalling firm
USPlabs, LLC, Dallas, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1370-2014 | 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. | 2,166,328 units | Class I | Terminated | 22 Jan 2014 |
| 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. | 1,065,783 units | Class I | Terminated | 22 Jan 2014 |
| F-1372-2014 | USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz | 645,826 units | Class I | Terminated | 22 Jan 2014 |
| F-1373-2014 | USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220) | 71,499 units | Class I | Terminated | 22 Jan 2014 |
| F-1374-2014 | USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220) | 10,306 units | Class I | Terminated | 22 Jan 2014 |
| F-1375-2014 | 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) | 21,325 units | Class I | Terminated | 22 Jan 2014 |
| F-1376-2014 | USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) RASPBERRY LEMONADE Manufactured for USPlabs, LLC (Dallas, TX 75220) | 10,278 units | Class I | Terminated | 22 Jan 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Food events that started in 2013
- 546
- Share of these events in Class I
- 37%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-1370-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 66813. https://recallregister.com/fda/i/66813/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines,…
- What quantity of product is in FDA event 66813?
- The event has 7 product records. The first record gives this quantity:
2,166,328 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2013 have the same class?
- 37% of the 546 food events that started in 2013 are in Class I.