Severity
Low
LowClass IIITerminated
FDA Food recall · Reported May 19, 2021
BTREX PLUS, Dietary Supplement 100 Caplets
cGMP Deviation: Presence of damaged tablets
Lopez Gonzalez Santana Corporation recalled BTREX PLUS, Dietary Supplement 100 Caplets - a low-severity action.
BTREX PLUS, Dietary Supplement 100 Caplets was recalled by Lopez Gonzalez Santana Corporation in May 19, 2021. Reason: cGMP Deviation: Presence of damaged tablets. Check the official notice for the remedy. Verify recall #F-0484-2021 with the FDA Food before acting.
The recall
Lopez Gonzalez Santana Corporation issued this low-severity FDA Food recall-cGMP Deviation: Presence of damaged tablets.
- Low
- severity level
- Class III
- classification
- May 19, 2021
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0484-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0484-2021) was formally reported on May 19, 2021, with the manufacturer initiating the action on April 20, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Lopez Gonzalez Santana Corporation is listed as the recalling firm, operating out of Rio Piedras, PR. Federal records list the affected scope as 311 Bottles.
The documented reason for this recall is: cGMP Deviation: Presence of damaged tablets Distribution data in the federal record shows the product reached: Domestic distribution only-PR. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
311 Bottles
Related Recalls
6
6 from same agency
Product description
BTREX PLUS, Dietary Supplement 100 Caplets
Reason for recall
cGMP Deviation: Presence of damaged tablets
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | F-0484-2021 |
| Date reported | May 19, 2021 |
| Date initiated | April 20, 2021 |
| Recalling firm | Lopez Gonzalez Santana Corporation |
| Firm location | Rio Piedras, PR |
| Affected scope | 311 Bottles |
| Distribution | Domestic distribution only-PR |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0484-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BTREX PLUS, Dietary Supplement 100 Caplets. Recalled by Lopez Gonzalez Santana Corporation. Units affected: 311 Bottles.
Why was this product recalled? ▼
cGMP Deviation: Presence of damaged tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Food on May 19, 2021. Severity: Low. Recall number: F-0484-2021.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution only-PR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0484-2021) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported May 19, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.