CLASS II Food recall · Reported 4 Jan 2017 · FDA Enforcement Report
Colon Therapy, bulk capsules recalled by Sunset Natural Products
Sunset Natural Products is recalling Colon Therapy, bulk capsules, distributed in Florida, Nevada. The recall was initiated on 13 Oct 2015 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0978-2017
- FDA event ID
- 74054
- Recalling firm
- Sunset Natural Products, Miami, FL
- Brand
- Colon Therapy
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2015
- FDA classified
- 28 Dec 2016
- Reported
- 4 Jan 2017
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Product category
- Dietary Supplements
Timeline
| 13 Oct 2015 | Recall initiated by company | |
| 28 Dec 2016 | Classified by FDA | +442 days |
| 4 Jan 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Colon Therapy, bulk capsules
Where it was distributed
Products distributed to Florida, Nevada and the Dominican Republic
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 020514 Exp. Date 05/17, Lot # 030514 Exp. Date 05/17, Lot # 040514 Exp. Date 05/17, Lot # 140514 Exp. Date 06/17, Lot # 150514 Exp. Date 06/17, Lot # 440514 Exp. Date 05/17, Lot # 500514 Exp. Date 05/17, Lot # 510514 Exp. Date 05/17, Lot # 520514 Exp. Date 05/17, Lot # 530514 Exp. Date 05/17, Lot # 540514 Exp. Date 06/17, Lot # 550514 Exp. Date 06/17, Lot # 560514 Exp. Date 06/17, Lot # 570514 Exp. Date 06/17, Lot # 580514 Exp. Date 06/17, Lot # 590514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 610514 Exp. Date 06/17, Lot # 620514 Exp. Date 07/17, Lot # 020714 Exp. Date 07/17, Lot # 240714 Exp. Date 07/17,Lot # 250714 Exp. Date 07/17, Lot # 260714 Exp. Date 07/17, Lot # 270714 Exp. Date 07/17, Lot # 280714 Exp. Date 07/17, Lot # 290714 Exp. Date 07/17, Lot # 300714 Exp. Date 07/17, Lot # 310714 Exp. Date 08/17, Lot # 320714 Exp. Date 08/17, Lot # 330714 Exp. Date 08/17, Lot # 340714 Exp. Date 08/17, Lot # 350714 Exp. Date 08/17, Lot # 380714 Exp. Date 09/17, Lot # 390714 Exp. Date 09/17, Lot # 400714 Exp. Date 09/17, Lot # 410714 Exp. Date 10/17, Lot # 280814 Exp. Date 10/17, Lot # 290814 Exp. Date 10/17, Lot # 300814 Exp. Date 10/17, Lot # 310814 Exp. Date 10/17, Lot # 320814 Exp. Date 10/17, Lot # 230914 Exp. Date 09/17, Lot # 270914 Exp. Date 10/17, Lot # 081014 Exp. Date 11/17, Lot # 091014 Exp. Date 11/17, Lot # 020615 Exp. Date 07/18, Lot # 040615 Exp. Date 07/18, Lot # 170615 Exp. Date 07/18, Lot # 180615 Exp. Date 08/18, Lot # 390615 Exp. Date 08/18, Lot # 480615 Exp. Date 08/18, Lot # 160715 Exp. Date 07/18
Where was it sold?
Products distributed to Florida, Nevada and the Dominican Republic
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
100 other products · FDA event 74054More recalls from Sunset Natural Products
All 173| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | True Vital recalled by Sunset Natural ProductsTrue Vital | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Lebytol recalled by Sunset Natural ProductsLebytol | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Oxy Extreme recalled by Sunset Natural ProductsOxy Extreme | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Kelp Acerola & Green Tea, bulk capsules recalledKelp Acerola | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Collagen & VIT recalled by Sunset Natural ProductsCollagen | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
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| Food | ANNOUNCED | Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali | Global Mix | Foreign Material | Nationwide |
| Food | CLASS I | Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR | ZMB Enterprises | Hidden Drug Ingredients | CA |
| Food | CLASS II | Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island | Mellish Island | Other | Nationwide |
| Food | CLASS I | Modern Warrior Ready, Dietary Supplement recalledModern Warrior | Modern Warrior Life | Hidden Drug Ingredients | Nationwide |
| Food | CLASS II | Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX | Provision Health | Undeclared Allergens | CA |