CLASS I Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report

Hydravax High Potency Diuretic Weight Loss Solution recalled

IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesALL LOTS

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1050-2014
FDA event ID
66965
Recalling firm
IQ Formulations, Sunrise, FL
Classification
Class I
Status
Terminated
Recall initiated
4 Nov 2013
FDA classified
30 Jan 2014
Reported
5 Feb 2014
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Labeling Errors

Timeline

4 Nov 2013Recall initiated by company
30 Jan 2014Classified by FDA+87 days
5 Feb 2014Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

Product as listed by the FDA

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

Where it was distributed

Nationwide, Hawaii and Puerto Rico

Nationwide HawaiiPuerto Rico

Questions about this recall

Is Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary recalled?

Yes. IQ Formulations recalled Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary on 4 Nov 2013. The recall is Class I and its status is Terminated. Recall number D-1050-2014.

Why was it recalled?

Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

Which lots are affected?

ALL LOTS

Where was it sold?

Nationwide, Hawaii and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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