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Sunset Natural Products Inc.

FEI 3002729075 · 7345 SW 45th St, Miami, Florida, 33155-4509, 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
2016-06-22
10 years ago

FDA record

  1. 2015-10-13
    RecallRecall F-1068-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Colageina 10 Caps, Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  2. 2015-10-13
    RecallRecall F-1069-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Colon Cleanser Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  3. 2015-10-13
    RecallRecall F-1070-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Nova Life Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  4. 2015-10-13
    RecallRecall F-1071-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Metabolang Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  5. 2015-10-13
    RecallRecall F-1072-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Growlean Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  6. 2015-10-13
    RecallRecall F-1073-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Amitad Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  7. 2015-10-13
    RecallRecall F-1074-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Collagen Hydrolyced Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  8. 2015-10-13
    RecallRecall F-1075-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Insulow Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  9. 2015-10-13
    RecallRecall F-1076-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    First Defense Probiotic Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  10. 2015-10-13
    RecallRecall F-1077-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Triflex Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  11. 2015-10-13
    RecallRecall F-1078-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Gluco + Chond + MSM, Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  12. 2015-10-13
    RecallRecall F-1079-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    De Pura Fibra Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  13. 2015-10-13
    RecallRecall F-1080-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Glow Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  14. 2015-10-13
    RecallRecall F-1081-2017 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Diet III Dietary Supplement (unknown container size)
    Source: FDA Enforcement Reports
  15. 2015-10-05
    RecallRecall F-0536-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Source: FDA Enforcement Reports
  16. 2015-10-05
    RecallRecall F-0537-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Argindione, sold as bulk of 50,000 capsules.
    Source: FDA Enforcement Reports
  17. 2015-10-05
    RecallRecall F-0538-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Source: FDA Enforcement Reports
  18. 2015-10-05
    RecallRecall F-0617-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Hepasil, sold in bulk of 500,000 capsules.
    Source: FDA Enforcement Reports
  19. 2015-10-05
    RecallRecall F-0539-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Source: FDA Enforcement Reports
  20. 2015-10-05
    RecallRecall F-0540-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Neuro-Cetin, sold in bulk 50,000 capsules.
    Source: FDA Enforcement Reports
  21. 2015-10-05
    RecallRecall F-0541-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Source: FDA Enforcement Reports
  22. 2015-10-05
    RecallRecall F-0542-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Source: FDA Enforcement Reports
  23. 2015-10-05
    RecallRecall F-0543-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Prostax Forte, sold in bulk of 50,000 capsules.
    Source: FDA Enforcement Reports
  24. 2015-10-05
    RecallRecall F-0544-2016 · Class 2 · Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
    Venocell, sold in bulk of 50,000 capsules.
    Source: FDA Enforcement Reports
  25. 2015-09-25
    Compliance actionFDA Injunction (CFSAN)
    FDA source
  26. 2014-09-30
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  27. 2014-04-10
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  28. 2013-03-19
    Warning letterFDA Warning Letter (CFSAN)
    FDA source
  29. 2012-09-11
    InspectionFDA inspection · Classification: Official Action Indicated (OAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source