The Recall Desk
CriticalFDA (Drugs)·D-921-2013·Announced 2013-09-04

Bethel 30 capsules recalled for undeclared active ingredients

Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules, packaged in 30 count bottles and distributed by BETHEL INC. in New York, New York. The recall involves 18,678 bottles with Lot # 120514 and an expiration date of 12/2014. The product was distributed nationwide and was also available for sale via the internet.

The recall was initiated because FDA analysis found the product contained undeclared sibutramine and phenolphthalein. These are active ingredients that were once marketed in the U.S. but were removed due to safety reasons. Consequently, the product is considered an unapproved new drug marketed without an approved NDA/ANDA.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Affected units
18,678

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 120514
  • EXP: 12/2014

Distribution

Distributed nationwide across the United States.

Same manufacturer · Bethel Nutritional Consulting, Inc

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