The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1374-2014·Announced 2014-06-18

FDA Recalls Super Fat Burning Bomb Capsules for Undeclared Ingredients

MyNicNaxs, Inc. is recalling Super Fat Burning Bomb Capsules because they contain undeclared active pharmaceutical ingredients, phenolphthalein and N-desmethylsibutramine.

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

The U.S. Food and Drug Administration (FDA) has issued a recall for Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes. The product is distributed by MyNicKnaxs, LLC, located in Deltona, Florida, and manufactured by MyNicNaxs, Inc. The recall covers all lots of the product and is distributed nationwide.

The recall was initiated because 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: phenolphthalein and N-desmethylsibutramine.

Consumers who have purchased this product should stop using it immediately. The FDA classifies this recall as Class I, which is the most serious type of recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Manufacturer
MyNicNaxs, Inc.
Category
Drug — Dietary Supplement
Hazard

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.

See all 10 products in this recall →

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