Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.