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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

TerminatedClass II

Company
Sunset Natural Products Inc.
Product
De Pura Fibra Dietary Supplement (unknown container size)
Recall date
October 13, 2015
Terminated
April 10, 2017
Source
FDA

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.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
De Pura Fibra Dietary Supplement (unknown container size) Not published in this source record Unknown 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 lot: Lot # 220215

Distribution

  • Products distributed to Florida
  • Nevada and the Dominican Republic

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1079-2017
Event ID
74054
Status
Terminated
Classification
Class II
Company
Sunset Natural Products Inc.
Product description
De Pura Fibra Dietary Supplement (unknown container size)
Quantity
Unknown
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 lot: Lot # 220215
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

Other products recalled under this same event

This recall shares FDA event ID 74054 with 9 other product entries in Public Health Trace.

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Diet III Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Glow Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Gluco + Chond + MSM, Dietary Supplement (unknown container s…
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Triflex Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
First Defense Probiotic Dietary Supplement (unknown containe…
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Insulow Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Collagen Hydrolyced Dietary Supplement (unknown container si…
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Amitad Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Growlean Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

Responsible company: Sunset Natural Products Inc.

Other recalls from Sunset Natural Products Inc.

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Diet III Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Glow Dietary Supplement (unknown container size)
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

FDA Recall United States Terminated Historical recordClass II

Sunset Natural Products Inc.

Product
Gluco + Chond + MSM, Dietary Supplement (unknown container s…
Published
January 4, 2017
Distribution
Products distributed to Florida, Nevada…

View recall →

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:

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.