FDA Drug recall D-921-2013
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- FDA Drug
- Class I
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class I recall of Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York by Bethel Nutritional Consulting, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-921-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-11 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bethel Nutritional Consulting |
| Distribution | US |
Product
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Reason
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.
Identifiers
| code_info | Lot #: 120514, EXP: 12/2014 |
|---|
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-921-2013%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.