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Pure Encapsulations, LLC

FEI 3000237804 · 490 Boston Post Rd, Sudbury, Massachusetts, 01776-3367, United States

3 import refusals on record (5 years)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)
3
Warning letters
1
Last FDA action
2024-01-26
2 years ago

FDA record

  1. 2024-01-26
    Import refusalShipment refused · FDA charge codes: 2300,260,3864,482 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line SCS-2509142-6/31/1 · Product code 54YCY99
    FDA source
  2. 2024-01-26
    Import refusalShipment refused · FDA charge codes: 2300,260,3864,482 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line SCS-2509142-6/21/1 · Product code 54YCY99
    FDA source
  3. 2024-01-26
    Import refusalShipment refused · FDA charge codes: 2300,260,3864,482 · Product: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
    Shipment line SCS-2509142-6/11/1 · Product code 54YCY99
    FDA source
  4. 2022-10-13
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  5. 2022-10-13
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  6. 2020-08-27
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  7. 2020-08-27
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  8. 2017-11-17
    RecallRecall F-0396-2018 · Class 3 · Product contains undeclared sulfites.
    Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2
    Source: FDA Enforcement Reports
  9. 2017-11-17
    RecallRecall F-0397-2018 · Class 3 · Product contains undeclared sulfites.
    pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7
    Source: FDA Enforcement Reports
  10. 2017-08-21
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  11. 2016-12-20
    Import refusalShipment refused · FDA charge codes: 2300,3864,482 · Product: HERBALS & BOTANICALS (NOT TEAS), N.E.C.
    Shipment line 799-8187629-0/11/1D · Product code 54FCH99
    FDA source
  12. 2014-05-27
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  13. 2012-05-17
    InspectionFDA inspection · Classification: Voluntary Action Indicated (VAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  14. 2011-12-23
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  15. 2011-08-30
    RecallRecall F-1741-2011 · Class 1 · The product contains undeclared eggs.
    Pure Encapsulations PreNatal Nutrients, hypo-allergenic dietary supplement, packaged in plastic bottles of 60 count (Product Code PRE6) and 120 count (Product code PRE12)
    Source: FDA Enforcement Reports
  16. 2011-08-23
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  17. 2011-08-23
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  18. 2009-09-22
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  19. 2007-11-06
    RecallRecall F-188-8 · Class 3 · Product may be contaminated with mold.
    Folic Acid Liquid, 120 ml , dietary supplement packaged in a plastic container with dropper UPC Code 7 66298 00112 8 Foreign Label: Pure encapsulations Reinsubstanzen "Folsaure (flussig)" 120 ml Distributed by: Pro Medico-pewa med Ha…
    Source: FDA Enforcement Reports
  20. 2007-08-09
    RecallRecall F-521-7 · Class 3 · Product may be contaminated with mold
    Pure Encapsulations Vitamin B12 Liquid, hypo-allergenic dietary supplement, Amber 30 ml (1 oz) bottle with a dropper UPC 7 6629800937 7
    Source: FDA Enforcement Reports