Bethel Advance (Bethel) – Unauthorized Drug Ingredients (2013)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Brand
Bethel Nutritional Consulting, Inc
Lot Codes / Batch Numbers
Lot 10092011, Exp 2014
Products Sold
Lot 10092011, Exp 2014
Bethel Nutritional Consulting, Inc is recalling Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, due to Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutram. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026