# FDA recall D-0631-2022

> **Je Dois Lavoir LLC** · Class I · drug recall initiated 2021-08-02.

## Product

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

## Reason for recall

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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

## Distribution

Sold online via website nationwide in the USA and Canada.

## Key facts

- **Recall number:** D-0631-2022
- **Recalling firm:** Je Dois Lavoir LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-02
- **Report date:** 2022-02-23
- **Termination date:** 2023-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Visalia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2022

## Citation

> AI Analytics. FDA recall D-0631-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0631-2022. Source: US FDA. Licensed CC0.

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