# FDA recall D-921-2013

> **Bethel Nutritional Consulting, Inc** · Class I · drug recall initiated 2013-06-11.

## Product

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.

## Distribution

Nationwide.  Product was also available for sale via internet

## Key facts

- **Recall number:** D-921-2013
- **Recalling firm:** Bethel Nutritional Consulting, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-11
- **Report date:** 2013-09-04
- **Termination date:** 2018-06-27

- **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-921-2013

## Citation

> AI Analytics. FDA recall D-921-2013. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-921-2013. Source: US FDA. Licensed CC0.

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