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Bella All Natural is recalling Bella Capsules because they contain undeclared sibutramine, a withdrawn controlled substance, making them unapproved drugs.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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The agency classification is FDA Class I, which mandates a minimum severity score of 4, but the presence of a withdrawn controlled substance with known safety concerns elevates the risk to the highest level.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 Sibutramine is a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns.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
- Category
- Drug — Dietary Supplement
- 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:
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