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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: 120514, EXP: 12/2014
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bethel Nutritional Consulting, Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: 120514, EXP: 12/2014

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-921-2013

Related Recalls

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.

Aug 5, 2013 Prescription Drugs Nationwide View Details →