openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
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drug · product 1 of 1
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
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.
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
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.
Code information
Lot #: 120514, EXP: 12/2014
Distribution pattern
Nationwide. Product was also available for sale via internet
