PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported June 4, 2014

Burn 7 Capsules, supplied in 30 capsules bottle

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

Recall #
D-1351-2014
Affected scope
120 bottles
Initiated
December 23, 2013
Verify with FDA Drug →
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Deseo Rebajar recalled Burn 7 Capsules, supplied in 30 capsules bottle - a critical-severity action.

Burn 7 Capsules, supplied in 30 capsules bottle was recalled by Deseo Rebajar in June 4, 2014. Reason: Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary suppleme…. Check the official notice for the remedy. Verify recall #D-1351-2014 with the FDA Drug before acting.

The recall

Deseo Rebajar issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary suppleme….

Critical
severity level
Class I
classification
June 4, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1351-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 Drug - 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.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Burn 7 Capsules, supplied in 30 capsules bottle

Reason for recall

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-1351-2014
Date reported June 4, 2014
Date initiated December 23, 2013
Recalling firm Deseo Rebajar
Firm location Fajardo, PR
Affected scope 120 bottles
Distribution Puerto Rico only

Profile values are sourced directly from the official FDA Drug 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 (D-1351-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug 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?
Burn 7 Capsules, supplied in 30 capsules bottle. Recalled by Deseo Rebajar. Units affected: 120 bottles.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Which agency issued this recall?
This recall was issued by the FDA Drug on June 4, 2014. Severity: Critical. Recall number: D-1351-2014.
Where was the recalled product distributed?
Distribution: Puerto Rico only.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

Similar Children & Baby Products · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported June 4, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026