The Recall Desk

FDA (Food) recall action 66813

USPlabs, LLC recalled 7 products on 2014-01-22

The FDA (Food) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2014-01-22
Critical
7
Units
3,991,345

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Risk

    USPlabs is recalling OxyELITE Pro Super Thermo Powder Plus Advanced Carnitine Transport System because it contains Aegeline, which is associated with serious liver damage or acute liver failure.

    Product
    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
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro dietary supplements containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    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.
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Super Thermo Due to Liver Damage Risk

    USPlabs is recalling OxyELITE Pro Super Thermo dietary supplements containing Aegeline due to reports of serious liver damage and acute liver failure.

    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.
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    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)
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    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)
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Due to Serious Liver Damage Reports

    USPlabs, LLC is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    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)
    Category
    Distribution
    0 states
  • CriticalFDA (Food)··2014-01-22

    USPlabs Recalls OxyELITE Pro Powder Linked to Liver Damage

    USPlabs is recalling OxyELITE Pro Super Thermo Powder containing Aegeline due to reports of serious liver damage and acute liver failure.

    Product
    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)
    Category
    Distribution
    0 states