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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 Supplements Recalled Due to Damaged Caplets

Agency Publication Date: June 11, 2021
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Summary

Lopez Gonzalez Santana Corporation is recalling 5,535 units of BTREX PLUS Dietary Supplement because of manufacturing deviations that resulted in the presence of damaged caplets within the bottles. The recall includes 894 bottles of the 100-count supplement and 4,641 bottles of the 2-count physician samples. These products were distributed exclusively in Puerto Rico and feature expiration dates in January 2022.

Risk

The presence of damaged tablets indicates a failure in quality control and manufacturing standards, which can affect the consistency, dosage, and integrity of the dietary supplement. Consumers should not ingest damaged or crumbling caplets as they may not provide the intended nutritional support or could present a choking hazard.

What You Should Do

  1. Check your supplement cabinet for BTREX PLUS Dietary Supplement in 100-count bottles or 2-count physician sample bottles.
  2. For the 100-count bottles, look for UPC 05380930801, Lot #30636, and an expiration date of 01/2022.
  3. For the 2-count physician samples, look for UPC 05380930802, Lot #30637, and an expiration date of 01. 2022.
  4. Immediately stop using any tablets from these specific lots, especially if you notice tablets are broken, cracked, or damaged.
  5. Return any affected bottles to the location where you received them (pharmacy, retail store, or physician's office) for a full refund or replacement.
  6. If you have experienced any adverse health effects after taking this supplement, contact your healthcare provider or pharmacist for guidance.
  7. For additional questions, contact the manufacturer or call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund for damaged dietary supplements

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: BTREX PLUS, Dietary Supplement (100 Caplets)
Item Code:
Recall #: F-0665-2021
UPC Codes:
05380930801
Lot Numbers:
30636 (Exp 01/2022)
Date Ranges: Expiration Date 01/2022
Product: BTREX PLUS, Dietary Supplement (2 caplets bottles - Physician Samples)
Item Code:
Recall #: F-0666-2021
UPC Codes:
05380930802
Lot Numbers:
30637 (Exp 01. 2022)
Date Ranges: Expiration Date 01. 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88029
Status: Resolved
Manufacturer: Lopez Gonzalez Santana Corporation
Sold By: Physician offices; Retailers in Puerto Rico
Manufactured In: United States
Units Affected: 2 products (894 bottles; 4641 units (2 tablet 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 · 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.