Severity
Low
LowClass IIITerminated
FDA Food recall · Reported May 26, 2021
BTREX PLUS, Dietary Supplement 100 Caplets
CGMP Deviations: Presence of damaged tablets
Compiled from official public sources by the editorial team.
Verify with FDA Food →
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 26, 2021. Reason: CGMP Deviations: Presence of damaged tablets. Check the official notice for the remedy. Verify recall #F-0541-2021 with the FDA Food before acting.
The recall
Lopez Gonzalez Santana Corporation issued this low-severity FDA Food recall — CGMP Deviations: Presence of damaged tablets.
- Low
- severity level
- Class III
- classification
- May 26, 2021
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0541-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0541-2021) was formally reported on May 26, 2021, with the manufacturer initiating the action on July 13, 2020. 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 662 bottles..
The documented reason for this recall is: CGMP Deviations: 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, 1 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.
Drugs & Medications recalls over time
Where this recall sits in its category — 14,048 drugs & medications recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
662 bottles.
Related Recalls
6
1 from same agency
Product description
BTREX PLUS, Dietary Supplement 100 Caplets
Reason for recall
CGMP Deviations: 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-0541-2021 |
| Date reported | May 26, 2021 |
| Date initiated | July 13, 2020 |
| Recalling firm | Lopez Gonzalez Santana Corporation |
| Firm location | Rio Piedras, PR |
| Affected scope | 662 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-0541-2021) 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: 662 bottles..
Why was this product recalled? ▼
CGMP Deviations: Presence of damaged tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Food on May 26, 2021. Severity: Low. Recall number: F-0541-2021.
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-0541-2021) 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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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported May 26, 2021.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.