Bethel Advance — Class I drug recall D-372-2014
Terminated recall by Bethel Nutritional Consulting, Inc, reported 2013-12-25, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsi
| Recall number | D-372-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bethel Nutritional Consulting, Inc, New York, NY, United States |
| Recall initiated | 2013-08-05 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2018-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 13,266 bottles |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00160126417509 |
| Lot numbers | 10092011, 2014 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-372-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.