PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported December 25, 2013

Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.

Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramin…

Recall #
D-372-2014
Affected scope
13,266 bottles
Initiated
August 5, 2013
Verify with FDA Drug →
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Bethel Nutritional Consulting, Inc recalled Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spiruli… - a critical-severity action.

Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spiruli… was recalled by Bethel Nutritional Consulting, Inc in December 25, 2013. Reason: Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethyls…. Check the official notice for the remedy. Verify recall #D-372-2014 with the FDA Drug before acting.

The recall

Bethel Nutritional Consulting, Inc issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethyls….

Critical
severity level
Class I
classification
December 25, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-372-2014 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 - 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.

Food recalls over time

Where this recall sits in its category - 25,457 food recalls on record

01,0002,0003,000 20052008201120142017202020232026 813
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

Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.

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-372-2014
Date reported December 25, 2013
Date initiated August 5, 2013
Recalling firm Bethel Nutritional Consulting, Inc
Firm location New York, NY
Affected scope 13,266 bottles
Distribution Nationwide, Puerto Rico, and internet sales

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-372-2014) 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?
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.. Recalled by Bethel Nutritional Consulting, Inc. Units affected: 13,266 bottles.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2013. Severity: Critical. Recall number: D-372-2014.
Where was the recalled product distributed?
Distribution: Nationwide, Puerto Rico, and internet sales.
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.

Compare this recall with Grade A White In-shell Chicken eggs packaged in the followi… → · All Food recalls

This recall: FDA Drug, reported December 25, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026