A mail-order pharmacy whose co-founder repeatedly criticized the Food and Drug Administration on “The Joe Rogan Experience” has been embroiled in an embarrassing recall by U.S. regulators, The Washington Post has learned.
Houston-based ReviveRX, whose outspoken co-founder Brigham Buehler appears regularly on Rogan’s podcast and speaks out about “corruption at the FDA” and “flaws in our health care system,” was found to have mistakenly mailed vials of testosterone to hundreds of patients instead of the weight-loss drugs they ordered, according to government records.
According to an FDA recall in April, the company shipped about 750 vials of testosterone to customers who had ordered tirzepatide, the active ingredient in the costly weight-loss drugs Maunjaro and Zepbound.
The FDA designated the ReviveRX recall a Class I recall, the most serious level, which means “there is a reasonable probability that serious health injury or death may result from use of or exposure to the violative product,” according to a statement from an FDA spokesperson.
ReviveRX general counsel Matthew Ludwig said the company voluntarily reported the testosterone mix-up to the FDA.
He declined to comment further on the April 20 recall, which the agency said remains “ongoing.”
According to a statement from the FDA, the FDA will end a recall based on whether a company has “recalled and seized all unrecalled product that could reasonably be expected to be recalled or has completed all product corrections.”
“Mislabeling a drug in this way is a gross negligence and suggests lax processes and procedures,” former FDA Acting Commissioner Steven Ostroff said of the April recall of Revive RX.
Taking testosterone incorrectly can result in symptoms such as hormone imbalance, mood swings, and changes in sexual function. According to The Healthyreported on the recall earlier.
According to the report, people with prostate or breast cancer may be at greater risk because their cancers are more sensitive to hormones.
“For most people who take testosterone, the effects are probably quite limited. [because] “You’re not going to get a year’s supply,” Ostrov said, “but it could have serious consequences for some people.”
Ostroff added that the recall was not announced in a press release. “Because every vial was filled according to a prescription. They knew who it went to.”
This isn’t the first time ReviveRX has issued a recall regarding tirzepatide: In May 2023, the company recalled the diet drug after dosages were deemed “less effective.” According to a notice from the insurer, Massachusetts General Brigham Health Plan: To members and distributors.
“In past recall cases, we have faced every challenge by building, fixing and
“We continually validate our quality systems through in-house pressure testing and training, third-party consulting inspections and regular interactions with state and federal regulators,” Ludwig said in a statement.
According to a June 30, 2023 letter from Rhonda Lloyd-Jones, FDA’s director of drug compliance, ReviveRX also violated the FDA when the agency sent inspectors to its Houston facility and found “unsanitary conditions.”
The recall is a blow to Buehler, who founded a company called Well2Well in 2018 that offers “in-depth blood testing” and virtual consultations, two years after co-founding ReviveRX.
Buehler, who has also appeared on podcasts with Robert F. Kennedy Jr., argued in a June 27 podcast with Rogan that the FDA is plagued with conflicts of interest.
“The FDA is largely funded by private industry,” Buehler told Logan, “and the FDA is influenced by those companies.”
ReviveRx is part of a growing number of so-called compounding pharmacies that have jumped on the diet drug bandwagon as Hollywood stars embrace the drugs and big drug companies struggle to meet demand.
In 2022, the FDA placed tirzepatide, the active ingredient in Eli Lilly’s Maunjaro and Zepbound, and semaglutide, the active ingredient in Novo Nordisk’s Wegovy and Ozempic, on the shortage list, which has opened the door for specialty pharmacies to counterfeit these drugs to meet demand.
In December, the FDA warned consumers about companies trying to take advantage of demand for these products to sell “fake” Ozempic.
The agency said several people have become ill after taking the counterfeit medicines.
Eli Lilly said in August that it was cutting the price of Zepbound by 50% and offering it in reduced doses in response to competition and demand.
