The Recall Desk
CriticalFDA (Drugs)·D-1150-2016·Announced 2016-07-13

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Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules because they contain undeclared phenolphthalein, a withdrawn ingredient with carcinogenic concerns.

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, 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Phenolphthalein is an ingredient previously found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity.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

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 →