365 SKINNY High Intensity Capsules recalled over undeclared sibutramine

Recall date

August 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Je Dois Lavoir LLC recalls 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Recall number

D-0631-2022

FDA classification

Class I

Brand / firm

Je Dois Lavoir LLC

Sold / distributed

Sold online via website nationwide in the USA and Canada.

Why it was recalled

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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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 is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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