The Recall Desk
CriticalFDA (Drugs)·D-0991-2015·Announced 2015-05-13

Ultra ZX Dietary Supplement Recalled for Undeclared Sibutramine and Phenolphthalein

Ultra ZX Labs is recalling Ultra ZX dietary supplements because FDA testing found undeclared sibutramine and phenolphthalein. The product was marketed without an approved NDA or ANDA.

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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Ultra ZX Labs, L.L.C. is recalling 636 bottles of Ultra ZX dietary supplements. The product contains Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, and Almidon Medico 84. The recall was initiated because FDA laboratory analysis confirmed the presence of undeclared sibutramine and phenolphthalein in the product.

The agency classified this as a Class I recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The distribution of the affected units included nationwide locations in the United States, Puerto Rico, and foreign markets in Spain and Ecuador.

Consumers who possess this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but the presence of undeclared pharmaceutical ingredients poses a significant health risk.

The recalled product

Product
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
Manufacturer
Ultra ZX Supplements
Category
Drug — Dietary Supplement
Hazard
Affected units
636

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/codes/bottles/packages.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · undeclared drug

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