The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1375-2014·Announced 2014-06-18

FDA Recalls Unapproved Weight Loss Pills Containing Undeclared Phenolphthalein

MyNicKnaxs is recalling weight reduction pills marketed without FDA approval because they contain undeclared 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

MyNicKnaxs, Inc. is recalling a weight reduction pill product marketed as a Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd. The product is supplied in 40-count boxes of 400 mg pills and was distributed nationwide by MyNicKnaxs, LLC in Deltona, Florida.

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 the undeclared active pharmaceutical ingredient phenolphthalein.

Consumers who have purchased this product should stop using it immediately. The recall applies to all lots of the product.

The recalled product

Product
Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Manufacturer
MyNicNaxs, Inc.
Category
Drug — Weight Loss
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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