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USPlabs, LLC

FEI 3007171192 · 10761 King William Dr, Dallas, Texas, 75220-2445, United States

3 warning letters on record

Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports

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Import alerts
0
Import refusals (5 years)
0
Warning letters
3
Last FDA action
2017-02-28
9 years ago

FDA record

  1. 2017-02-28
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  2. 2017-02-28
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  3. 2013-11-09
    RecallRecall F-1370-2014 · Class 1 · 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.
    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.
    Source: FDA Enforcement Reports
  4. 2013-11-09
    RecallRecall F-1371-2014 · Class 1 · 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.
    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.
    Source: FDA Enforcement Reports
  5. 2013-11-09
    RecallRecall F-1372-2014 · Class 1 · 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.
    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; …
    Source: FDA Enforcement Reports
  6. 2013-11-09
    RecallRecall F-1373-2014 · Class 1 · 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.
    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)
    Source: FDA Enforcement Reports
  7. 2013-11-09
    RecallRecall F-1374-2014 · Class 1 · 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.
    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)
    Source: FDA Enforcement Reports
  8. 2013-11-09
    RecallRecall F-1375-2014 · Class 1 · 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.
    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)
    Source: FDA Enforcement Reports
  9. 2013-11-09
    RecallRecall F-1376-2014 · Class 1 · 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.
    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)
    Source: FDA Enforcement Reports
  10. 2013-11-05
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  11. 2013-10-11
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  12. 2013-06-10
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  13. 2012-12-04
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  14. 2012-10-23
    Import refusalShipment refused · FDA charge codes: 2120 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line 322-0757273-0/7/1 · Product code 54YCZ99
    FDA source
  15. 2012-10-23
    Import refusalShipment refused · FDA charge codes: 2120 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line 322-0757273-0/6/1 · Product code 54YCZ99
    FDA source
  16. 2012-10-23
    Import refusalShipment refused · FDA charge codes: 2120 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line 322-0757273-0/5/1 · Product code 54YCZ99
    FDA source
  17. 2012-04-24
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  18. 2012-02-21
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  19. 2010-07-07
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Foodborne Biological Hazards
    FDA source
  20. 2010-07-07
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source