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Hi-Tech Pharmaceuticals Inc.

FEI 3001859902 · 6015 Unity Dr Ste B, Norcross, Georgia, 30071-3575, United States

2 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
2
Last FDA action
2023-03-24
3 years ago

FDA record

  1. 2023-03-24
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  2. 2021-05-12
    RecallRecall F-0647-2021 · Class 2 · The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).
    Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9
    Source: FDA Enforcement Reports
  3. 2021-04-03
    RecallRecall F-0498-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE BANANA CREAM PIE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89846 7 & 5LB, UPC 6 49241 87829 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  4. 2021-04-03
    RecallRecall F-0499-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE FUDGE POP DIETARY SUPPLEMENT NET WT. 2lb jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071 UPC 8 11836 02223 0
    Source: FDA Enforcement Reports
  5. 2021-04-03
    RecallRecall F-0500-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89876 4 & 5lb, UPC 6 49241 87830 8 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  6. 2021-04-03
    RecallRecall F-0501-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE CINNAMON GRAHAM CRACKER DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89001 0 & 5lb, UPC 6 49241 87831 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  7. 2021-04-03
    RecallRecall F-0502-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 & 5lb, UPC 6 49241 87832 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  8. 2021-04-03
    RecallRecall F-0503-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE NEOPOLITAN ICE CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 8 11836 02251 3 & 5lb, UPC 8 11836 02252 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  9. 2021-04-03
    RecallRecall F-0504-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE ORANGE CREAMSICLE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89856 6 & 5lb, UPC 6 49241 87833 9 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  10. 2021-04-03
    RecallRecall F-0505-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE SMORES DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89002 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  11. 2021-04-03
    RecallRecall F-0506-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE STRAWBERRY MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89866 5 & 5lb, UPC 6 49241 87835 3 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  12. 2021-04-03
    RecallRecall F-0507-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE VANILLA ICE CREAM DIETARY SUPPLEMENT NET WT. 5lb, UPC 6 49241 87837 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  13. 2021-04-03
    RecallRecall F-0508-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE VANILLA MILKSHAKE DIETARY SUPPLEMENT NET WT. 2LB, UPC 6 49241 89886 5 & 5lb, UPC 6 49241 87836 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  14. 2021-04-03
    RecallRecall F-0509-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
    ISOMORPH 28 PURE WHEY iSOLATE HONEY GRANOLA DIETARY SUPPLEMENT NET WT. 2LB, UPC 8 11836 02303 9 & 5lb, UPC 8 11836 02302 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Source: FDA Enforcement Reports
  15. 2021-04-03
    RecallRecall F-0510-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains undeclared egg, milk, wheat & soy.
    IFN iFORCE NUTRITION MASS GAINZ PROTEIN MATRIX BROWN SUGAR MAPLE OATMEAL COOKIE NET WT 2.2 KG/4.85 LBS container UPC 8 19500 01010 1 Mfg. For Dist. By Trib?????? Enterprises, LLC Vista, CA 92081
    Source: FDA Enforcement Reports
  16. 2021-04-03
    RecallRecall F-0511-2021 · Class 1 · During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".
    HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836 02341 1 & 5lbs. (2.2kg) UPC 8 11836 02349 7 manufactured by Hi-Tech Pharmaceuticals, 6015-B Unity Dr. Norcross, GA
    Source: FDA Enforcement Reports
  17. 2021-03-30
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Foodborne Biological Hazards
    FDA source
  18. 2021-03-30
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  19. 2019-04-11
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  20. 2015-04-22
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  21. 2013-11-08
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  22. 2012-02-29
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  23. 2009-12-08
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  24. 2009-06-30
    Import refusalShipment refused · FDA charge codes: 11,2120 · Product: EPHEDRA (HERBAL & BOTANICALS, NOT TEAS)
    Shipment line JF7-0073340-1/1/1D · Product code 54FCB09
    FDA source
  25. 2009-06-30
    Import refusalShipment refused · FDA charge codes: 11,2120 · Product: EPHEDRA (HERBAL & BOTANICALS, NOT TEAS)
    Shipment line JF7-0073340-1/1/1C · Product code 54FCB09
    FDA source
  26. 2009-06-30
    Import refusalShipment refused · FDA charge codes: 11 · Product: COCCULUS
    Shipment line JF7-0073340-1/1/1A · Product code 54FCB75
    FDA source
  27. 2006-05-16
    RecallRecall F-158-7 · Class 2 · Dietary Supplement makes unapproved drug claim that it can prevent Bird Flu and also fails to label one of its ingredients, star anise, properly.
    Avian-Rx¿ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg, Hi-Tech Pharmaceuticals, Inc., 5015 B Unity Drive, Norcross, GA 30871, sold over-the-counter, labeled to contain a combina…
    Source: FDA Enforcement Reports