RecallRadar

FDA Drug recall D-1165-2016

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

On 2016-07-13 the FDA classified a Class I recall of Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180 by Xtreme Z Distributors, citing marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1165-2016
ClassificationClass I
Statusongoing
Initiated2015-07-02
Published2016-07-13
Last updated2026-09-13 11:51 UTC
CompanyXtreme Z Distributors
DistributionUS

Product

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Reason

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Identifiers

code_infoLot 1220062085, Exp. 09/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1165-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.