The Recall Desk
CriticalFDA (Drugs)·D-0877-2016·Announced 2016-06-01

Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.

Plain-English summary

Centro Naturista is recalling Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottles. The product is distributed by SmartLipo365 in Arlington, TX, and was marketed nationwide. The recall covers all lots of the product.

The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine, desmethylsibutramine, and phenolphthalein. These undeclared ingredients are not approved for use in dietary supplements and can pose serious health risks.

Consumers who have purchased Smart Lipo Dietary Supplement capsules should stop using the product immediately. They should contact the distributor or manufacturer for further instructions on how to return the product or obtain a refund.

The recalled product

Product
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Manufacturer
Centro Naturista

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 2 recalled by Centro Naturista 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 2 products in this recall →

Same manufacturer · Centro Naturista

See all →