XCEL Advanced Capsules Recalled for Undeclared Phenolphthalein
Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules because they contain undeclared phenolphthalein, a withdrawn ingredient with carcinogenic concerns.
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, and the presence of a carcinogenic substance in an unapproved drug constitutes a critical health risk.
Plain-English summary
Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules, 350mg, 60-count bottles, manufactured for JNS Health. The product was marketed as a dietary supplement but was found to be tainted with undeclared phenolphthalein.
Phenolphthalein is an ingredient previously found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity. Its presence makes the product an unapproved drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall covers all lots of the product, which was distributed nationwide. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- XCEL ADVANCED Capsules, 350mg, 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.
See all 14 products in this recall →Related recalls
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