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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. 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
  2. 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
  3. 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
  4. 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
  5. 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