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RECALL RECORD — CLASS IIRecall closedF-1024-2017/FDA enforcement
Sunset Natural Products INC.·Dietary Supplements·Oct 13, 2015

Bioxtron Dietary Supplement (Unknown Container Size)

What you need to know

Class II

  • What happened

    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…

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. Current good manufacturing practice failures can affect product identity, strength, quality or purity.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDADistribution not listedMore supplements

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Product identification

Source: FDA FOOD

Brand nameSunset Natural Products INC.
Recalling firmSunset Natural Products INC.Miami, FL, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • 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 # 190414, 210414, 220414, 230414, 280514, 290514, 300514, 310514, 490514, 290614, 600714, 610714, 130814, 240814, 250814, 440814, 160914, 200914, 450914, 131014, 241014, 361014, 441014, 141114, 151114, 291114, 161214, 191214, 211214, 321214, 331214, 220115, 290115, 300115, 430315, 090415, 100415, 110415, 260415, 11515, 120515, 080614, 580614, 610514, 160714, 170714.
Distribution area

Products distributed to Florida, Nevada and the Dominican Republic

United States

Quantity affectedNot provided by the FDA.
Recall initiationFDA report date: January 4, 2017
FDA recall numberF-1024-2017

Beyond the headline

The recall, in context

Sunset Natural Products INC. initiated this supplements recall on October 13, 2015. The FDA enforcement report states: 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. The FDA report lists distribution as: Products distributed to Florida, Nevada and the Dominican Republic.

The FDA enforcement report describes the reason as: 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.

Bioxtron Dietary Supplement (Unknown Container Size) was made or distributed by Sunset Natural Products INC. in Miami, FL, United States. This page reflects FDA report F-1024-2017, dated January 4, 2017.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, current good manufacturing practice failures can affect product identity, strength, quality or purity.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Bioxtron Dietary Supplement (Unknown Container Size) recall?

Sunset Natural Products INC. recalled Bioxtron Dietary Supplement (Unknown Container Size) in an FDA Class II enforcement action reported as F-1024-2017. 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…

What are the symptoms of Product safety recall exposure?

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Who is most at risk from Product safety recall?

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

How do I get a refund from Sunset Natural Products INC.?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall F-1024-2017 and keep the packaging, lot code and proof of purchase if you have them.

Is the Sunset Natural Products INC. recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-1024-2017. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.