The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1146-2016·Announced 2016-07-13

FDA Recalls SlimeX-15 Capsules Containing Undeclared Sibutramine

The FDA is recalling SlimeX-15 Capsules because they contain undeclared sibutramine, a withdrawn drug. Consumers should stop using the product.

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 mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling SlimeX-15 Capsules, 15 mg, 30-count bottles. The product was marketed by Signature Pharmaceuticals Ltd. and manufactured in India by HAB Pharmaceuticals & Research Limited. The recalling firm is Bee Extremely Amazed LLC.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as a dietary supplement, the product was found to be tainted with undeclared sibutramine. Sibutramine is an appetite suppressant that was previously withdrawn from the U.S. market for safety reasons, making its presence in this product an unapproved drug.

The recall covers all lots of the product, which was distributed nationwide. Consumers who have purchased SlimeX-15 Capsules should stop using the product immediately and contact their healthcare provider if they have any concerns.

The recalled product

Product
SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197
Manufacturer
Bee Extremely Amazed LLC
Category
Drug — Dietary Supplement
Hazard

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 14 recalled by Bee Extremely Amazed LLC 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 14 products in this recall →

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