# FDA recall D-372-2014

> **Bethel Nutritional Consulting, Inc** · Class I · drug recall initiated 2013-08-05.

## Product

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.

## Distribution

Nationwide, Puerto Rico, and internet sales

## Key facts

- **Recall number:** D-372-2014
- **Recalling firm:** Bethel Nutritional Consulting, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-05
- **Report date:** 2013-12-25
- **Termination date:** 2018-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-372-2014

## Citation

> AI Analytics. FDA recall D-372-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-372-2014. Source: US FDA. Licensed CC0.

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