Drug recall: Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Class I FDA enforcement event 65441. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Bethel Nutritional Consulting, Inc started this drug recall on 11 Jun 2013. The firm address in the FDA record is in New York, NY. FDA put the recall in Class I. FDA event 65441 has 1 product record. The first FDA enforcement report date is 4 Sep 2013. The record gives the status Terminated, with the termination date 27 Jun 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide. Product was also available for sale via internet
Recalling firm
Bethel Nutritional Consulting, Inc, New York, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-921-2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York | 18,678 bottles | Class I | Terminated | 4 Sep 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class I
- 18%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2014 | SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. | Drug | Class I | 1 |
| 19 Dec 2014 | B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Stree | Drug | Class II | 1 |
| 5 Aug 2013 | Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spiruli | Drug | Class I | 2 |
Official channels
- FDA enforcement report D-921-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 65441. https://recallregister.com/fda/i/65441/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide. Product was also available for sale via internet
- What quantity of product is in FDA event 65441?
- The FDA record gives this quantity:
18,678 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 18% of the 370 drug events that started in 2013 are in Class I.