FDA Drug recall D-372-2014
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count b…
- FDA Drug
- Class I
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class I recall of Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count b… by Bethel Nutritional Consulting, citing marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramin….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-372-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-05 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bethel Nutritional Consulting |
| Distribution | US |
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
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.
Identifiers
| upc | 160126417509 |
|---|---|
| code_info | Lot 10092011, Exp 2014 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-372-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.