Recall Register

Food recall: Bionix, 30 capsules per bottle

Class II FDA enforcement event 74054. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Sunset Natural Products Inc. started this food recall on 13 Oct 2015. The firm address in the FDA record is in Miami, FL. FDA put the recall in Class II. FDA event 74054 has 163 product records. The first FDA enforcement report date is 4 Jan 2017. The record gives the status Terminated, with the termination date 10 Apr 2017.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Products distributed to Florida, Nevada and the Dominican Republic

Recalling firm

Sunset Natural Products Inc., Miami, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: FDA Mandated.

Products

163 product records in the event.

FDA event 74054: product records
Recall numberProductQuantityClassStatusReport date
F-0909-2017Bionix, 30 capsules per bottle6,500 Bottles (195,000 capsules)Class IITerminated4 Jan 2017
F-0910-2017Performens, 30 capsules per bottle2000 Bottles (120,000 Caps)Class IITerminated4 Jan 2017
F-0911-2017SoMaks, 30 capsules per bottle1000 Bottles (30,000 capsules)Class IITerminated4 Jan 2017
F-0912-2017Project #2, 90 capsules per bottle1,000 Bottles (90,000 capsules)Class IITerminated4 Jan 2017
F-0913-2017Project #3, 60 capsules per bottle1940 Bottles (120,000 capsules)Class IITerminated4 Jan 2017
F-0914-2017Nutra Pro, 60 ct. per bottle2,160 Bottles (198,000 capsules)Class IITerminated4 Jan 2017
F-0915-2017Oxy Extreme, 90 capsules per bottle1,200 bottles (108,000 capsules)Class IITerminated4 Jan 2017
F-0916-2017Test Booster, 90 or 60 capsules per bottle5292 Bottles (337,000 capsules)Class IITerminated4 Jan 2017
F-0917-2017Fat Burner, 45 capsules per bottle2,000 Bottles (90,000 capsules)Class IITerminated4 Jan 2017
F-0918-2017Thor, 60 capsules per bottle1,963 Bottles (180,000 capsules)Class IITerminated4 Jan 2017
F-0919-2017Night Stallion, (80,000 capsule bulk)80,000 CapsulesClass IITerminated4 Jan 2017
F-0920-2017Crea Care, (100,000 capsule bulk)100,000 capsulesClass IITerminated4 Jan 2017
F-0921-2017Carni Care, (50,000 capsule bulk)50,000 capsulesClass IITerminated4 Jan 2017
F-0922-2017H-Stane, 60 capsules per bottle500 Bottles, (30,000 capsules)Class IITerminated4 Jan 2017
F-0923-2017Agma Care, (50,000 capsule bulk)50,000 capsule bulkClass IITerminated4 Jan 2017
F-0924-2017Mdrol, 90 capsules per bottle1,000 Bottles (90,000 capsules)Class IITerminated4 Jan 2017
F-0925-2017Natural Fat Burner (45,000 capsule bulk)45,000 capsule bulkClass IITerminated4 Jan 2017
F-0926-2017Madre Cell, 60 capsules per bottle1000 bottles (60,000 capsules)Class IITerminated4 Jan 2017
F-0927-2017Healthy Male, 60 capsules per bottle816 Bottles (49,000 capsules)Class IITerminated4 Jan 2017
F-0928-2017HGH, 100 capsules per bottle350 Bottles (35,000 capsules)Class IITerminated4 Jan 2017
F-0929-2017Collagen & VIT C, 60 capsules per bottle23,100 Bottles (1,364,000 capsules)Class IITerminated4 Jan 2017
F-0930-2017Colostrum, 90 capsules per bottle288 Bottles (26,000 capsules)Class IITerminated4 Jan 2017
F-0931-2017Joint I, 60 capsules per bottle36 Bottles (12,400 capsulesClass IITerminated4 Jan 2017
F-0932-2017Liver Energy, 100 capsules per bottle124 Bottles (18,000 capsules)Class IITerminated4 Jan 2017
F-0933-2017Artrosamin, 250,000 capsules per bulk order3,000,000 capsulesClass IITerminated4 Jan 2017
F-0934-2017Hepasil, (various bulk amounts)2,650,000 capsulesClass IITerminated4 Jan 2017
F-0935-2017Argindione, (50,000 capsule bulk)50,000 capsulesClass IITerminated4 Jan 2017
F-0936-2017Dygeszyme, (50,000 capsule bulk)150,000 capsulesClass IITerminated4 Jan 2017
F-0937-2017Prostax Forte, (50,000 capsule bulk)100,000 capsulesClass IITerminated4 Jan 2017
F-0938-2017Magnumn, (30 per bottle)400 Bottles, (30 per bottle)Class IITerminated4 Jan 2017
F-0939-2017Magnun Plus, (30 per bottle)900 Bottles (27,000 capsules)Class IITerminated4 Jan 2017
F-0950-2017Equs, (30 capsules per bottle)1800 bottles, (54,000 capsules)Class IITerminated4 Jan 2017
F-0951-2017Equs Mas, (30 capsules per bottle)1,600 Bottles, (48,000 capsules)Class IITerminated4 Jan 2017
F-0952-2017Lebytol, 30 capsules per bottle2,400 Bottles, (72,000 capsules)Class IITerminated4 Jan 2017
F-0953-2017ABS Reducer, 60 capsules per bottle2,000 Bottles, (120,000 capsules)Class IITerminated4 Jan 2017
F-0954-2017Weight Control, 60 capsules per bottle2000 Bottles, (35,000 capsules)Class IITerminated4 Jan 2017
F-0955-2017Nutrigen, 60 capsules per bottle3,000 Bottles, (180,000 capsules)Class IITerminated4 Jan 2017
F-0956-2017Weight 2.0, 120 capsules per bottle1,000 Bottles, (120,000 capsules)Class IITerminated4 Jan 2017
F-0957-2017Tyrosine Formula, 90 capsules per bottle250 Bottles, ( 22,500 capsules)Class IITerminated4 Jan 2017
F-0958-2017Chardon De Marie, 60 capsules per bottle23,665 Bottles, (1,420,000 capsules)Class IITerminated4 Jan 2017
F-0959-2017Colageina Gold, 195 g Jars10,663 JarsClass IITerminated4 Jan 2017
F-0960-2017Prostaliv, 60 capsules per bottle20,499 Bottles, (1,500,000 capsules)Class IITerminated4 Jan 2017
F-0961-2017Prostaliv New, 60 capsules per bottle15,250 Bottles, (915,000 capsules)Class IITerminated4 Jan 2017
F-0962-2017Moinsage, 60 capsules per bottle28,666 Bottles, (1,720,000 capsules)Class IITerminated4 Jan 2017
F-0963-2017Colageina Orange, (195 g per Jar)5,812 Jar's (195G per Jar)Class IITerminated4 Jan 2017
F-0964-2017Vital Cure, 30 capsules per bottle189,533 Bottles, (6,136,000 capsules)Class IITerminated4 Jan 2017
F-0965-2017True Vital, 30 capsules per bottle1,000 Bottles, (30,000 capsules)Class IITerminated4 Jan 2017
F-0966-2017Pinateina500 BottlesClass IITerminated4 Jan 2017
F-0967-2017Avit, bulk capsules891,000 capsulesClass IITerminated4 Jan 2017
F-0968-2017Coclss, bulk capsules2,400,000 capsulesClass IITerminated4 Jan 2017
F-0969-2017Zinc Gluconate, bulk capsules1,540,000 capsulesClass IITerminated4 Jan 2017
F-0970-2017Karma, bulk capsules65,000 capsulesClass IITerminated4 Jan 2017
F-0971-2017Aloe Vera 500 mg, bulk capsules12,310,000 capsulesClass IITerminated4 Jan 2017
F-0972-2017Mecogm, bulk capsules1,155,000 capsulesClass IITerminated4 Jan 2017
F-0973-2017Wesmag, bulk capsules408,000 capsulesClass IITerminated4 Jan 2017
F-0974-2017Horny Goat Weed, bulk capsules1,100,000Class IITerminated4 Jan 2017
F-0975-2017Bima, bulk capsules550,000 capsulesClass IITerminated4 Jan 2017
F-0976-2017Arganine & Pine Bark, bulk capsules1,335,000 capsulesClass IITerminated4 Jan 2017
F-0977-2017Yaco Capsules, bulk capsules3,900,000Class IITerminated4 Jan 2017
F-0978-2017Colon Therapy, bulk capsules19,455,300Class IITerminated4 Jan 2017

The table shows 60 of 163 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Food events that started in 2015
607
Share of these events in Class II
46%
Product records in this event
163Median of the firm: 163
Events of the firm on the register
2

Other events of the firm

Other FDA enforcement events of Sunset Natural Products Inc.
InitiatedProduct (first record)TypeClassRecords
5 Oct 2015Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural ProductsFoodClass II10

Official channels

Cite this page

Recall Register. FDA enforcement event 74054. https://recallregister.com/fda/ii/74054/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA food enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Products distributed to Florida, Nevada and the Dominican Republic
What quantity of product is in FDA event 74054?
The event has 163 product records. The first record gives this quantity: 6,500 Bottles (195,000 capsules)
How did the recall start?
The FDA record says: FDA Mandated
How many food recalls of 2015 have the same class?
46% of the 607 food events that started in 2015 are in Class II.