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Xymogen Manufacturing

FEI 3004315824 · 6900 Kingspointe Pkwy, Orlando, Florida, 32819-6544, United States

1 warning letter 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
1
Last FDA action
2024-08-13
2 years ago

FDA record

  1. 2024-08-13
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  2. 2022-08-08
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  3. 2018-08-16
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  4. 2016-03-15
    Import refusalShipment refused · FDA charge codes: 2300,482 · Product: ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C.
    Shipment line UPS-4889956-1/1/1 · Product code 54GCH99
    FDA source
  5. 2014-09-10
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  6. 2013-08-16
    RecallRecall F-0815-2014 · Class 3 · Product was labeled as a medical food as opposed to a dietary supplement.
    XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N…
    Source: FDA Enforcement Reports
  7. 2013-08-16
    RecallRecall F-0816-2014 · Class 3 · Product was labeled as a medical food as opposed to a dietary supplement.
    LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
    Source: FDA Enforcement Reports
  8. 2013-05-24
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  9. 2013-05-01
    RecallRecall F-1523-2013 · Class 1 · Undeclared Soy and Milk on the label.
    XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles
    Source: FDA Enforcement Reports
  10. 2012-07-06
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  11. 2011-12-14
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  12. 2011-08-05
    RecallRecall F-1628-2011 · Class 1 · On 08/05/2011 Xymogen initiated a recall of 3 varieties of OrganiX Bars: Omega-3, Lot 1083110 Exp. 31- Aug-11; Spice Lot 1072110 & 2072110 Exp 21-Jul-11; and Greens Lot 4072110 & 5072110 Exp 21-Jul-11. The Xymogen Bars may contain undeclared peanut protein.
    "***XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Greens Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 (50g) Bars NET WT.21.16 oz (600g) Organic Whole Food Bar***Certified Organic Ingredient…
    Source: FDA Enforcement Reports
  13. 2011-08-05
    RecallRecall F-1629-2011 · Class 1 · On 08/05/2011 Xymogen initiated a recall of 3 varieties of OrganiX Bars: Omega-3, Lot 1083110 Exp. 31- Aug-11; Spice Lot 1072110 & 2072110 Exp 21-Jul-11; and Greens Lot 4072110 & 5072110 Exp 21-Jul-11. The Xymogen Bars may contain undeclared peanut protein.
    "***XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Omega 3 Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 -50 g Bars NET WT.21.16 oz (600g)***Certified Organic Ingredients: Organic Cashew But…
    Source: FDA Enforcement Reports
  14. 2011-08-05
    RecallRecall F-1630-2011 · Class 1 · On 08/05/2011 Xymogen initiated a recall of 3 varieties of OrganiX Bars: Omega-3, Lot 1083110 Exp. 31- Aug-11; Spice Lot 1072110 & 2072110 Exp 21-Jul-11; and Greens Lot 4072110 & 5072110 Exp 21-Jul-11. The Xymogen Bars may contain undeclared peanut protein.
    "***XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Spice Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 (50g) Bars NET WT.21.16 oz (600g)***Certified Organic Ingredients: Organic Cashew Butte…
    Source: FDA Enforcement Reports
  15. 2011-08-01
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Colors and Cosmetics Technology
    FDA source
  16. 2011-08-01
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source