The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1371-2014·Announced 2014-06-18

Weight Loss Capsules Recalled for Undeclared Phenolphthalein Ingredient

MyNicNaxs, Inc. is recalling REDUCE WEIGHT FRUTA PLANTA Capsules because they contain undeclared phenolphthalein and were marketed without FDA approval.

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 corresponds to a reasonable probability of serious adverse health consequences or death, meeting the criteria for a Critical severity score.

Plain-English summary

MyNicNaxs, Inc. is recalling REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes. The product was distributed by MyNicKnaxs, LLC. in Deltona, FL, and was available nationwide. The recall involves 100 boxes, and all lots are affected.

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 an undeclared active pharmaceutical ingredient: phenolphthalein.

Consumers who have purchased this product should stop using it immediately. They should contact the recalling firm for further instructions on how to return the product or obtain a refund.

The recalled product

Product
REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL
Manufacturer
MyNicNaxs, Inc.
Category
Drug — Weight Loss Supplement
Hazard
Affected units
100

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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