The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0981-2015·Announced 2015-05-13

FDA Recalls iNSANE Bee Pollen Capsules Containing Unapproved Drugs

The FDA is recalling iNSANE Bee Pollen capsules because they contain undeclared phenolphthalein and fluoxetine, making them unapproved drugs.

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 Critical severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling iNSANE Bee Pollen capsules, 200 mg, 60-count bottles. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The manufacturer is Detox Transforms, and the product was developed by Signature.

The recall was initiated because the product was found to contain undeclared phenolphthalein and fluoxetine. The presence of these undeclared ingredients makes iNSANE an unapproved drug. The specific lot number is 0000:02, with an expiration date of 06/20/17. The product was distributed nationwide.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for instructions.

The recalled product

Product
iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
Manufacturer
Detox Transforms
Category
Drug — Dietary Supplement
Hazard
Affected units
200

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 (2)

  • Lot: 0000:02
  • Exp 06/20/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Detox Transforms 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 5 products in this recall →

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Same manufacturer · Detox Transforms

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Same hazard · undeclared ingredients

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