Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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.
What was recalled
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-921-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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