US Drug Recall Register
Class I · High risk Terminated Initiated Jun 11, 2013 (13 years ago)

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.