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Sunset Natural Products Inc.

173 recall records on file.

2017

20 records

Class IITerminatedRecall F-0909-2017

Product description

Bionix, 30 capsules per bottle

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.

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Event ID
74054
Code info
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 and exp date: Lot # 380414 Exp Date 04/17, Lot #310614 Exp Date 07/17, Lot # 391014 Exp Date 12/17
Product quantity
6,500 Bottles (195,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0910-2017

Product description

Performens, 30 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 390614 Exp. Date 07/17
Product quantity
2000 Bottles (120,000 Caps)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0911-2017

Product description

SoMaks, 30 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 300415 Exp. Date 07/18
Product quantity
1000 Bottles (30,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0912-2017

Product description

Project #2, 90 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 011014 Exp. Date 10/17
Product quantity
1,000 Bottles (90,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0913-2017

Product description

Project #3, 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 021014 Exp. Date 10/17, Lot # 041114 Exp. Date 11/17
Product quantity
1940 Bottles (120,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0914-2017

Product description

Nutra Pro, 60 ct. per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 031014 Exp. Date 10/17
Product quantity
2,160 Bottles (198,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0915-2017

Product description

Oxy Extreme, 90 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 181014 Exp. Date 10/17
Product quantity
1,200 bottles (108,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0916-2017

Product description

Test Booster, 90 or 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 011114 Exp. Date 11/17, Lot # 010215 Exp. Date 02/18, Lot # 130215 Exp. Date 02/18, Lot # 191014 Exp. Date 10/17
Product quantity
5292 Bottles (337,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0917-2017

Product description

Fat Burner, 45 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 211014 Exp. Date 10/17
Product quantity
2,000 Bottles (90,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0918-2017

Product description

Thor, 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 051214 Exp. Date 12/17, Lot # 160515 Exp. Date 05/18, Lot # 260515 Exp Date 05/18
Product quantity
1,963 Bottles (180,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0919-2017

Product description

Night Stallion, (80,000 capsule bulk)

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 420315 Exp. Date 03/18
Product quantity
80,000 Capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0920-2017

Product description

Crea Care, (100,000 capsule bulk)

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 400415 Exp. Date 04/18
Product quantity
100,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0921-2017

Product description

Carni Care, (50,000 capsule bulk)

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 410415 Exp. Date 04/18
Product quantity
50,000 capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0922-2017

Product description

H-Stane, 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 170515 Exp. Date 05/18
Product quantity
500 Bottles, (30,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0923-2017

Product description

Agma Care, (50,000 capsule bulk)

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 180515 Exp. Date 05/18
Product quantity
50,000 capsule bulk
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0924-2017

Product description

Mdrol, 90 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 450615 Exp. Date 07/18
Product quantity
1,000 Bottles (90,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0925-2017

Product description

Natural Fat Burner (45,000 capsule bulk)

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.

View full record
Event ID
74054
Code info
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 and expiration date: Lot # 250715 Exp. Date 07/18
Product quantity
45,000 capsule bulk
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0926-2017

Product description

Madre Cell, 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 510315 Exp. Date 04/18, Lot # 410815 Exp. Date 09/18
Product quantity
1000 bottles (60,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0927-2017

Product description

Healthy Male, 60 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 220714 Exp. Date 07/17, Lot # 190115 Exp. Date 01/18, Lot # 320615 Exp. Date 06/18
Product quantity
816 Bottles (49,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017
Class IITerminatedRecall F-0928-2017

Product description

HGH, 100 capsules per bottle

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.

View full record
Event ID
74054
Code info
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 # 230714 Exp. Date 07/17, Lot # 260215 Exp. Date 02/18
Product quantity
350 Bottles (35,000 capsules)
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Voluntary / mandated
FDA Mandated
Initial firm notification
Letter
Product type
Food
Recalling firm location
7345 SW 45th St, N/A, Miami, FL, United States
Recall initiation date
10/13/2015
Center classification date
12/28/2016
Termination date
04/10/2017