XCEL Capsules Recalled for Undeclared Fluoxetine and Phenolphthalein
Bee Extremely Amazed LLC is recalling XCEL Capsules marketed as a dietary supplement because they contain undeclared fluoxetine and phenolphthalein.
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
Bee Extremely Amazed LLC is recalling XCEL Capsules, 300 mg, 60-count bottles, which were manufactured for JNS Health. The product was marketed as a dietary supplement but was found to be tainted with undeclared fluoxetine and phenolphthalein.
Fluoxetine is an FDA-approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Phenolphthalein is an ingredient previously found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity. The presence of these ingredients makes the product an unapproved drug.
The recall covers all lots of the product, which was distributed nationwide. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
- Manufacturer
- Bee Extremely Amazed LLC
- Category
- Drug — Dietary Supplement
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Bee Extremely Amazed LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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