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Class IITerminated in FDA datasetRecall initiated Oct 13, 2015

Colon Therapy, bulk capsules

Recalling firm: Sunset Natural Products Inc.

Why it was 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…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Apr 10, 2017.

Check your package

Compare the exact product and package details with the label you have.

ProductColon Therapy, bulk capsules

FDA code information

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

Match the product, package size, and code together. A missing match does not guarantee safety.

Full FDA record and distribution details

Original product description

Colon Therapy, bulk capsules

Extracted codes and context

TypeCode / valueContext
lot020514ee 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
lot020615. 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
lot020714. 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
lot030514, 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
lot040514ration 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
lot040615. 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
lot081014. 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
lot091014. 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
lot140514. 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
lot150514. 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
lot160715. Date 08/18, Lot # 390615 Exp. Date 08/18, Lot # 480615 Exp. Date 08/18, Lot # 160715 Exp. Date 07/18
lot170615. 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
lot180615. 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
lot230914. 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
lot240714. 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
lot250714p. 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
lot260714p. 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
lot270714p. 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
lot270914. 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
lot280714. 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
lot280814. 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
lot290714. 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
lot290814. 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
lot300714. 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
lot300814. 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
lot310714. 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
lot310814. 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
lot320714. 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
lot320814. 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
lot330714. 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
lot340714. 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
lot350714. 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
lot380714. 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
lot390615. 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
lot390714. 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
lot400714. 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
lot410714. 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
lot440514. 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
lot480615. 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
lot500514. 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
lot510514. 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
lot520514. 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 # 56051
lot530514. 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 # 57051
lot540514. 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 # 58051
lot550514. 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 # 59051
lot560514 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
lot570514 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
lot580514 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
lot590514. 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
lot600514. 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
lot600514. 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
lot610514. 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
lot620514. 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

Original FDA recall reason

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.

Recall details

Recall number
F-0978-2017
Event ID
74054
FDA status
Terminated
Initiated
Oct 13, 2015
Reported
Jan 4, 2017
Classified
Dec 28, 2016
Terminated
Apr 10, 2017
Quantity
19,455,300
Location
Miami, FL, United States
Initiation type
FDA Mandated
Notification
Letter

Where it was distributed

Products distributed to Florida, Nevada and the Dominican Republic

FDA source record · F-0978-2017

Data updated September 16, 2026. View official FDA data ↗

Follow official FDA and manufacturer guidance.