Lopez Gonzalez Santana Corporation Recall: CGMP Deviations: Presence of damaged tablets

🇺🇸 United States

1. May 25, 2021 - Recall initiated
2. June 23, 2021 - Reported by source
3. January 20, 2022 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0665-2021

Event ID

88029

Status

Terminated

Classification

Class III

Company

Lopez Gonzalez Santana Corporation

Product description

BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801

Quantity

894 bottles

Reason

CGMP Deviations: Presence of damaged tablets

Recall initiation date

May 25, 2021

Report date

June 23, 2021

Classification date

Not published in this source record

Termination date

January 20, 2022

Distribution pattern

Domestic distribution only-PR

UPC, lot, and code information

UPC 05380930801; Lot #30636, Expiration Date 01/2022

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 88029 with 1 other product entry in Public Health Trace.

Responsible company: Lopez Gonzalez Santana Corporation

Other recalls from Lopez Gonzalez Santana Corporation

A map highlighting the states named in the source's distribution description.

Distributed No data published

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map

State	Distributed
Puerto Rico	1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class III mean?

A situation in which use of or exposure to a product is not likely to cause adverse health consequences.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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