Sunset Natural Products Inc. 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.

🇺🇸 United States

1. October 13, 2015 - Recall initiated
2. January 4, 2017 - Reported by source
3. April 10, 2017 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0978-2017

Event ID

74054

Status

Terminated

Classification

Class II

Company

Sunset Natural Products Inc.

Product description

Colon Therapy, bulk capsules

Quantity

19,455,300

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 initiation date

October 13, 2015

Report date

January 4, 2017

Classification date

Not published in this source record

Termination date

April 10, 2017

Distribution pattern

Products distributed to Florida, Nevada and the Dominican Republic

UPC, lot, and 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

Voluntary or mandated

FDA Mandated

Initial notification method

Letter

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 74054 with 10 other product entries in Public Health Trace.

Responsible company: Sunset Natural Products Inc.

Other recalls from Sunset Natural Products Inc.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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