Key Takeaway

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York by Bethel Nutritional Consulting, Inc was recalled on June 11, 2013. The hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients th...

FDA Drug Class I Terminated

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

Recalled: June 11, 2013 ~18,678 bottles units affected D-921-2013

Description

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

Hazard / Reason

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.

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

Drugs

Company Information

Bethel Nutritional Consulting, Inc

New York, NY, United States

View all 5 recalls by Bethel Nutritional Consulting, Inc →

Distribution

Nationwide. Product was also available for sale via internet

Related Recalls

FDA Drug Class I

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

December 19, 2014
FDA Drug Class II

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

December 19, 2014
FDA Drug Class I

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, UP

August 5, 2013
FDA Drug Class I

Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212)

August 5, 2013

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.