The Recall Desk
LowFDA (Food)·F-0665-2021·Announced 2021-06-23

BTREX PLUS Dietary Supplement Recalled for Damaged Tablets

Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement (100 caplets, UPC 05380930801, Lot #30636, Exp. 01/2022) due to the presence of damaged tablets resulting from manufacturing deviations.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a cosmetic defect (damaged tablets) and manufacturing process deviation with no reported illnesses or injuries. The hazard is product integrity rather than safety-related contamination or injury risk, consistent with the Low severity category.

Plain-English summary

Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement 100 Caplets (UPC 05380930801) in response to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 894 bottles with Lot #30636 and an expiration date of 01/2022, distributed domestically in Puerto Rico.

The reason for the recall is the presence of damaged tablets identified during manufacturing. This deviation from manufacturing standards was discovered during the quality control process.

Consumers who have purchased BTREX PLUS with the affected lot number are advised to stop using the product. Consumers should contact Lopez Gonzalez Santana Corporation for instructions regarding the return or disposal of affected bottles.

The recalled product

Product
BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801
Manufacturer
Lopez Gonzalez Santana Corporation
Hazard
  • damaged-product
  • manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #30636
  • Expiration Date 01/2022

Distribution

Distributed in 1 state:

  • PR