Key Takeaway

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL by Je Dois Lavoir LLC was recalled on August 2, 2021. The hazard: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was w...

FDA Drug Class I Terminated

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Recalled: August 2, 2021 ~783 bottles units affected D-0631-2022

Description

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Hazard / Reason

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

Class I: Dangerous or defective product that could cause serious health problems or death.

Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.

Products Affected

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Drugs

Company Information

Je Dois Lavoir LLC

Visalia, CA, United States

View all 1 recalls by Je Dois Lavoir LLC →

Distribution

Sold online via website nationwide in the USA and Canada.

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.