Fruta BIO Capsules Recalled for Undeclared Active Pharmaceutical Ingredients
MyNicNaxs, Inc. is recalling Fruta BIO 400 mg capsules because they contain undeclared sibutramine and phenolphthalein.
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 severity score of 5 according to the rubric.
Plain-English summary
MyNicNaxs, Inc. is recalling Fruta BIO 400 mg capsules, supplied in 30-count boxes, distributed by MyNicKnaxs, LLC in Deltona, FL. The recall covers all lots of the product.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared active pharmaceutical ingredients: sibutramine and phenolphthalein.
Consumers who have purchased Fruta BIO 400 mg capsules should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.
The recalled product
- Product
- Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
- Manufacturer
- MyNicNaxs, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 2
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 10 recalled by MyNicNaxs, Inc. 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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