The Recall Desk
SevereFDA (Drugs)·D-0631-2022·Announced 2022-02-23

365 SKINNY High Intensity Capsules Recalled for Undeclared Sibutramine

Je Dois Lavoir LLC is recalling 365 SKINNY High Intensity Capsules (600 mg, 30-count bottles) because the product contains undeclared sibutramine, a drug previously withdrawn from the US market due to safety concerns.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall meets FDA Class I criteria as stated by the agency. The product is marketed without an approved NDA/ANDA and contains a drug withdrawn from the market due to safety concerns, representing a significant health risk.

Plain-English summary

Je Dois Lavoir LLC is recalling 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottles, distributed under the brand BODY BALANCE INTERNACIONAL. FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

Approximately 783 bottles of the affected product were sold online via website nationwide in the USA and Canada. The affected lot is Lot 102-26, with an expiration date of December 2022.

Consumers who have purchased this product should stop use immediately. Consumers with questions or concerns should contact Je Dois Lavoir LLC or consult a healthcare provider.

The recalled product

Product
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Manufacturer
Je Dois Lavoir LLC
Category
Drug — Dietary Supplement / Weight Loss
Hazard
  • undeclared-sibutramine
  • unapproved-drug
  • withdrawn-drug

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 (2)

  • Lot 102-26
  • Exp Dec 2022

Distribution

Distributed nationwide across the United States.

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