The Recall Desk
CriticalFDA (Drugs)·D-0593-2018·Announced 2018-03-14

Bella Capsules Recalled for Undeclared Sibutramine Content

Bella All Natural is recalling Bella Capsules because they contain undeclared sibutramine, a withdrawn controlled substance, making them unapproved drugs.

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The agency classification is FDA Class I, which mandates a minimum severity score of 4, but the presence of a withdrawn controlled substance with known safety concerns elevates the risk to the highest level.

Plain-English summary

Bella All Natural is recalling 32 bottles of Bella Capsules, 600mg, 30-count. The product was distributed in California to online customers and retail stores. The specific lot number is MFD:10.15.2017, Exp.10/14/2019.

The FDA is recalling this product because it contains undeclared sibutramine. Sibutramine is a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns. The presence of this substance renders the product an unapproved drug for which safety and efficacy have not been established.

Consumers who purchased this product should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Manufacturer
Bella All Natural
Affected units
32

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 #: MFD:10.15.2017
  • Exp.10/14/2019.

Distribution

Distributed in 1 state: