The Recall Desk
CriticalFDA (Drugs)·D-1050-2014·Announced 2014-02-05

FDA Recalls Hydravax Weight Loss Supplement for Undeclared Prescription Drug

IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution because it contains an undeclared prescription diuretic, Triamterene.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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

IQ Formulations, LLC is recalling Hydravax High Potency Diuretic Weight Loss Solution, a dietary supplement manufactured and distributed by Metabolic Nutrition. The product is being recalled because it contains an undeclared diuretic called Triamterene. Triamterene is an FDA-approved prescription-only medication used to treat edema, which makes the supplement an unapproved new drug.

The recall covers all lots of the product, which is described as containing 45 capsules per bottle. The product was distributed nationwide, including Hawaii and Puerto Rico.

Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com

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.

The notice also names 2 states specifically: