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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Food
Food & Beverages/Dietary Supplements

Lopez Gonzalez Santana Corporation: BTREX PLUS Dietary Supplement Recalled for Damaged Tablets

Agency Publication Date: May 19, 2021
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Summary

Lopez Gonzalez Santana Corporation has recalled approximately 32,841 units of BTREX PLUS dietary supplements because the tablets were found to be damaged, which is a violation of current Good Manufacturing Practices (CGMP). The recall affects both 100-count bottles and 2-count physician sample packets distributed exclusively in Puerto Rico. Consumers should check their supplement packaging for specific lot numbers and expiration dates to see if their product is affected. Because this is a supplement recall involving damaged physical goods, consumers are advised to stop using the affected tablets and contact their healthcare provider or the manufacturer for guidance.

Risk

The presence of damaged tablets indicates a failure in manufacturing quality control. Damaged or broken tablets can affect the integrity of the product and may not meet established quality standards, although no specific adverse health effects have been reported in this incident.

What You Should Do

  1. Check your supplement packaging for the product name 'BTREX PLUS' and identify the container size (2-count sample packet or 100-count bottle).
  2. For 2-count Physician Samples, verify the UPC 05380930802 and look for lot number 32179 with an expiration date of 9/2022, or lot number 33278 with an expiration date of 12/2022.
  3. For 100-count bottles, look for lot number 33491 with an expiration date of 12/22.
  4. If your product matches the affected lot numbers and expiration dates, stop using the supplement immediately.
  5. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or before continuing with a new supply.
  6. Return any unused product to the place of purchase for a full refund or contact Lopez Gonzalez Santana Corporation for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund

Full refund upon return of product.

How to: Return the product to the place of purchase for a full refund or contact the manufacturer for further instructions.
๐Ÿ“‹Option 2: Other Action

Healthcare provider consultation.

How to: Contact your healthcare provider or pharmacist for guidance regarding the use of these damaged tablets.

Affected Products

Product: BTREX PLUS Dietary Supplement (2 Caplets, Physician Samples)
Item Code:
Recall #: F-0540-2021
UPC Codes:
05380930802
Lot Numbers:
32179 (Exp. 9/2022)
33278 (Exp. 12/2022)
Date Ranges: Exp. 9/2022, Exp. 12/2022
Product: BTREX PLUS Dietary Supplement (100 Caplets)
Item Code:
Recall #: F-0541-2021
Lot Numbers:
33491 (Exp. 12/22)
Date Ranges: Exp. 12/22

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87759
Status: Resolved
Manufacturer: Lopez Gonzalez Santana Corporation
Sold By: Physician offices; Retailers in Puerto Rico
Manufactured In: United States
Units Affected: 2 products (lots #32179  1405 and Lot #33278 - 0.; 662 bottles.)
Distributed To: Puerto Rico

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.