A mail-order pharmacy whose co-founder has repeatedly criticized the Food and Drug Administration on “The Joe Rogan Experience” has been caught up in an embarrassing recall by the US agency, The Post has learned.
Houston-based ReviveRX — whose outspoken co-founder Brigham Buhler has been a regular on Rogan’s podcasts, opining on “FDA corruption” and “systemic flaws in our healthcare” — mistakenly mailed vials of testosterone to hundreds of patients instead of the weight-loss drugs they had ordered, government records show.
The company shipped some 750 vials of testosterone to customers who had instead ordered tirzepatide, the active ingredient in the pricey weight-loss drugs Mounjaro and Zepbound, according to an April recall by the FDA.
The FDA designated the ReviveRX recall a class I — the most serious level, meaning that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequence or death,” according to a statement from an FDA spokesperson.
ReviveRX’s general counsel Matthew Ludowig noted the company voluntarily brought the testosterone mix-up to the FDA’s attention.
He declined to comment on further the April 20 recall, noting that it remains listed by the agency as “ongoing.”
The FDA ends recalls based on whether a company has “retrieved and impounded all outstanding product that could reasonably be expected to be recovered or has completed all product corrections,” according to the FDA statement.
“It’s a serious error to mislabel a pharmaceutical in this way and it suggests that they have lax processes and procedures in place,” Stephen Ostroff, a former acting commissioner of the FDA, said of ReviveRX’s April recall.
People who take testosterone by mistake could suffer from hormonal imbalances, mood swings, changes in sexual function, according to The Healthy, which earlier reported on the recall.
Those suffering from prostate or breast cancers could be at greater risk because of their hormone sensitivity, the report said.
“Consequences for most people who took the testosterone were probably fairly limited in scope [because] it didn’t involve getting a year’s supply,” Ostroff said. “But it could have serious consequences for some people.”
The recall was not publicly announced in a press release, Ostroff added, “because every one of the vials was filled in response to a prescription. They knew who it went to.”
It’s not the first time ReviveRX had a recall involving tirzepatide. In May 2023, the company recalled dosages of the diet drug because they were determined to be “sub-potent,” according to a notice by insurer Mass General Brigham Health Plan to its members and distributors.
“With regard to prior recall events, we view every challenge as an opportunity to build, modify and
enhance our organization,” Ludowig said in a statement. “We consistently vet our quality systems through internal pressure testing and training, third-party consulting inspections, and routine interactions with state and federal regulators.”
ReviveRX also ran afoul of the FDA when the agency sent inspectors to its Houston facility and found “insanitary conditions,” according to a June 30, 2023 letter from Ronda Loyd-Jones, an FDA compliance director for pharmaceuticals.
The latest recall is a black eye for Buhler who, two years after co-founding ReviveRX, started a company in 2018 called Well2Well that offers “in depth blood lab analysis” and virtual consultations.
Buhler, who also has appeared on podcasts with Robert F. Kennedy Jr., claimed during a June 27 podcast with Rogan that the FDA is plagued by conflicts of interest.
“A majority of the FDA’s funding comes from private industry,” Buhler told Rogan. “And they are being influenced by these companies.”
ReviveRx is among the growing number of so-called compounding pharmacies that have jumped on the diet drug bandwagon as Big Pharma companies have struggled to meet demand after Hollywood stars embraced them.
In 2022, the FDA placed tirzepatide — the active ingredient in Eli Lilly’s Mounjaro and Zepbound — and semaglutide — the active ingredient in Novo Nordisk’s Wegovy and Ozempic — on its shortage list. The designation opened up the floodgates for specialized pharmacies to replicate the drugs with off-brand versions to meet demand.
In December, the FDA warned consumers about companies that are trying to cash in on the demand for these products by peddling “fake” Ozempic.
A handful of people have become sick after taking counterfeit drugs, the agency reported.
In August, Eli Lilly said it’s slashing the price of Zepbound by 50% and offering it at a lower dosage in response to the competition and demand.
