RECALL RECORD — CLASS IIIRecall closedF-0484-2021/FDA enforcement

Btrex Plus, Dietary Supplement 100 Caplets

What you need to know

Class III
  • What happened

    CGMP Deviation: Presence of damaged tablets

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. 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 FDAPRMore supplements

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Product identification

Source: FDA FOOD

Brand nameLopez Gonzalez Santana Corporation
Recalling firmLopez Gonzalez Santana CorporationRio Piedras, PR, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot # 33277 Exp date:12/22
Distribution area
PR

Domestic distribution only-PR

United States

Quantity affected311 Bottles
Recall initiationFDA report date: May 19, 2021
FDA recall numberF-0484-2021

Beyond the headline

The recall, in context

Lopez Gonzalez Santana Corporation initiated this supplements recall on April 20, 2021. The FDA enforcement report states: CGMP Deviation: Presence of damaged tablets. The FDA report lists distribution as: Domestic distribution only-PR.

The FDA enforcement report describes the reason as: CGMP Deviation: Presence of damaged tablets

Btrex Plus, Dietary Supplement 100 Caplets was made or distributed by Lopez Gonzalez Santana Corporation in Rio Piedras, PR, United States. This page reflects FDA report F-0484-2021, dated May 19, 2021.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, current good manufacturing practice failures can affect product identity, strength, quality or purity.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

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 Btrex Plus, Dietary Supplement 100 Caplets recall?

Lopez Gonzalez Santana Corporation recalled Btrex Plus, Dietary Supplement 100 Caplets in an FDA Class III enforcement action reported as F-0484-2021. CGMP Deviation: Presence of damaged tablets

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 Lopez Gonzalez Santana Corporation?

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-0484-2021 and keep the packaging, lot code and proof of purchase if you have them.

Is the Lopez Gonzalez Santana Corporation 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-0484-2021. 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.