US Drug Recall Register
Class I · High risk Terminated Initiated Aug 2, 2021 (5 years ago)

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

Class I — High risk. Reasonable probability of serious harm or death.

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

What was recalled

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

Recalling firm
Je Dois Lavoir LLC
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0631-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.