OxyElite Pro: The Supplement That Caused a Hepatitis Outbreak in Hawaii, from the Same Company That Made Jack3d
USPlabs somehow made TWO of the most dangerous supplements in history, and the leetspeak product names should have been the first red flag
In 2013, doctors in Hawaii noticed something unusual: a cluster of patients presenting with severe liver damage, all without the typical risk factors — no heavy drinking, no hepatitis B or C, no medication interactions. What they did have in common was OxyElite Pro, a "fat burner" supplement manufactured by a Dallas-based company called USPlabs.
The cluster grew into an outbreak. Over 60 cases of liver damage were eventually linked to OxyElite Pro in Hawaii alone. One person died. Multiple people required liver transplants. The CDC launched an investigation. The FDA issued a warning. And USPlabs — the company that had already built a reputation for aggressive, boundary-pushing supplement formulations — suddenly found itself at the center of a federal criminal investigation.
Here's where it gets genuinely unhinged: USPlabs also manufactured Jack3d, a pre-workout supplement that contained DMAA — a stimulant linked to at least five deaths, including two U.S. soldiers. The same company made two of the most dangerous supplements in modern history. Two products from one company. Multiple deaths. Multiple organ transplants. An outbreak classified by the CDC using the same language they use for foodborne illness and bioterrorism.
The company's product names — "OxyElite Pro," "Jack3d" — read like they were designed by a teenager who thinks replacing letters with numbers is cool. This aesthetic choice, in retrospect, is the supplement-label equivalent of a restaurant misspelling "sanitary" on their health inspection certificate. If the name suggests the marketing team prioritizes edge over credibility, the formulation might too.
The Vision: Burn Fat (and Possibly Your Liver)
OxyElite Pro was marketed as a thermogenic fat burner — a supplement that raises your body temperature to increase caloric burn. The original formula contained DMAA (1,3-dimethylamylamine), a powerful stimulant that the FDA later determined was not a legitimate dietary ingredient. When the FDA cracked down on DMAA, USPlabs reformulated OxyElite Pro with a new ingredient: aegeline, extracted from the bael tree.
Aegeline had essentially zero safety data in humans. USPlabs put it in a supplement, sold millions of units, and let American consumers serve as the clinical trial. The consumers were not informed they were the clinical trial. The informed consent process consisted of the word "SUPPLEMENT FACTS" on the back of the label.
The reformulated OxyElite Pro with aegeline was the version linked to the Hawaii hepatitis outbreak. Whether aegeline specifically caused the liver damage, or a contaminant in the manufacturing process, or an interaction between ingredients has never been conclusively determined. What was determined is that dozens of people's livers failed after taking this product, and USPlabs continued selling it for weeks after the first cases were reported.
The Glorious User Experience
Kai from Honolulu, HI — ★☆☆☆☆
"I was one of the Hawaii cases. I took OxyElite Pro for three weeks. Week four, I turned yellow. Not 'slightly off-color.' Yellow. My eyes. My skin. My urine looked like motor oil. I was diagnosed with acute hepatitis. My liver enzymes were over a thousand — normal is under 40. I spent eleven days in the hospital watching doctors try to figure out what had poisoned me. The answer was on my bathroom counter in a bottle that said 'Fat Burner' on the label. I wanted to burn fat. I burned my liver instead. One star."
Mike from San Diego, CA — ★☆☆☆☆
"I took Jack3d before it was pulled. Heart palpitations, shaky hands, couldn't sleep. Stopped taking it. Switched to OxyElite Pro because it was made by the same company and I figured they'd learned from Jack3d. They had not learned from Jack3d. They had learned nothing from Jack3d. They had, in fact, doubled down on making supplements that attack your organs. The company's product development philosophy appears to be 'what if we made your insides mad?' One star."
Dr. Sarah Park, Hawaii State Epidemiologist (2013) — Professional assessment
"This is very concerning. We have a cluster of severe liver disease, some requiring transplant, linked to a dietary supplement with inadequately studied ingredients. The scope and severity of this outbreak is unusual for a consumer product."
“The cluster grew into an outbreak”
Click to TweetAnonymous USPlabs Customer — ★☆☆☆☆
"I looked at the OxyElite Pro label and couldn't pronounce half the ingredients. This should have been my sign. If a supplement contains words you need a biochemistry degree to pronounce and a liability waiver to consume, it's not a supplement. It's an experiment. And you're the experiment. One star."
The Truth: When the DOJ Gets Involved, You've Really Screwed Up
The FDA doesn't often refer supplement cases to the Department of Justice. The supplement industry is largely self-regulated, which means the FDA's role is mostly reactive — they wait for people to get hurt and then issue warnings. For the DOJ to get involved means the FDA believes actual crimes were committed, not just regulatory violations.
USPlabs got the DOJ.
In November 2015, federal prosecutors indicted USPlabs executives on charges including conspiracy to introduce misbranded and adulterated dietary supplements, money laundering, and fraud. The indictment alleged that USPlabs lied about the origins and testing of its ingredients, claiming that aegeline was a natural plant extract when it was actually manufactured in a Chinese chemical factory. The company allegedly fabricated origin stories for its ingredients, created fake testing documents, and continued selling products after learning they were causing harm.
In 2017, USPlabs pleaded guilty to charges related to the introduction of adulterated supplements and agreed to forfeit $2 million. Two company executives received prison sentences. The company that made OxyElite Pro and Jack3d — two supplements linked to multiple deaths and dozens of organ failures — was criminally convicted.
The Hawaii outbreak alone involved over 60 confirmed cases of liver damage, including liver transplants and one death. But the full scope of OxyElite Pro's damage is likely much larger. Like all supplement adverse events, most cases go unreported. The people who took OxyElite Pro and experienced "just" fatigue, nausea, or mild liver elevation — symptoms they attributed to a hard workout or a bad meal — never made it into the official count.
The bael tree extract (aegeline) had been used in traditional Indian medicine, but in doses and preparations radically different from the concentrated form in OxyElite Pro. The jump from "traditional remedy" to "concentrated extract in a mass-market supplement" was made without the studies that would normally bridge that gap, because the supplement industry doesn't require those studies. The bridge was built while people were walking on it. Some of them fell off.
The Verdict
OxyElite Pro is what happens when a supplement company treats its customers as unpaid test subjects for ingredients that haven't been adequately studied, manufactured in facilities that haven't been adequately inspected, and marketed with claims that haven't been adequately verified. The company that made it also made Jack3d. Two products. Multiple deaths. A DOJ indictment. Prison sentences.
The supplement industry's regulatory framework allowed all of this to happen before anyone with authority stepped in. The FDA acted after people were hospitalized. The DOJ acted after people died. The supplement sat on shelves at GNC for months after the first liver failure cases were reported, because pulling a product requires more bureaucratic effort than selling one.
OxyElite Pro is no longer sold. USPlabs is no longer operational. The executives are convicted. But the regulatory framework that allowed them to sell an untested ingredient to millions of people and wait for the outbreak hasn't fundamentally changed. The next OxyElite Pro is, statistically, already on a shelf somewhere, waiting for enough adverse events to trigger the next investigation.
We rate it 1 out of 5 safe supplements.
If you want a pre-workout or fat burner that won't trigger a CDC investigation, see our alternatives below.
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✅What to Buy Instead
Transparent Labs Lean Pre-Workout
Full-disclosure label with clinically dosed ingredients. No proprietary blends. No mystery chemicals. Every ingredient listed with its dose, because hiding ingredients is what criminal companies do.
Legion Phoenix Fat Burner
Research-backed thermogenic with published ingredient amounts and third-party testing. Has never caused a hepatitis outbreak. A low bar, but one OxyElite couldn't clear.
Examine.com Subscription
Independent supplement research database. Learn what actually works — with evidence — before putting anything in your body. Knowledge is cheaper than a liver transplant.
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