The Recall Desk
CriticalFDA (Drugs)·D-0880-2016·Announced 2016-06-01

FDA Recalls Weight Loss Capsules Containing Undeclared Sibutramine and Phenolphthalein

Lucy's Weight Loss is recalling Shorts on The Beach Strong Formula capsules nationwide because they contain undeclared sibutramine 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 per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottles. The product is manufactured and distributed by Lucy's Weight Loss System (dba. Waisted With Lucy) in Arlington, Texas. The recall covers all lots and is distributed nationwide.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine and phenolphthalein. These substances are not approved for use in dietary supplements and may pose health risks.

Consumers who have purchased this product should stop using it immediately. They should contact the manufacturer for further instructions on how to return the product or obtain a refund.

The recalled product

Product
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Manufacturer
Lucy's Weight Loss (dba. Waisted With Lucy)
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 3 recalled by Lucy's Weight Loss (dba. Waisted With Lucy) 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 3 products in this recall →

Related recalls

Same manufacturer · Lucy's Weight Loss (dba. Waisted With Lucy)

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Same hazard · undeclared drug

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