Today, the FDA again advised consumers to avoid purchasing and using Umary, a product marketed as a dietary supplement to treat pain; it contains the undeclared prescription drug ingredients diclofenac and omeprazole. The Agency first warned consumers about this product and another, similar product marketed as Amazy in June 2024 and reissued that warning in July of the same year about these unapproved drug products.
Yet, here we are, in February 2026, almost two full years later, with yet another warning (here). The Agency obviously has significant concerns about these products (the labels for which wrongly identify them as hyaluronic acid) but they still seem to be making their way into the hands of unwitting consumers.
Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) and “may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines,” all of which are serious adverse events. In addition, omeprazole is a proton pump inhibitor (PPI) and “may also mask stomach issues such as erosions, ulcers and stomach cancer, and it can also interact with other medications.” The FDA’s own labs have confirmed the presence of these ingredients in the products while noting that neither is declared on the label. Consumers could also be taking approved prescription drug products containing these active ingredients, which would likely exacerbate any adverse effects. The Agency says it “has received an increase in adverse event reports with the use of Umary products since the agency issued a warning in June 2024.” This is despite the fact that the Agency noted, at the time of the warning, that it was aware the two manufacturers mentioned had recalled the Umary products. Apparently, however, they are still available for purchase by consumers in the marketplace.
The FDA’s efforts to keep harmful products like these out of the hands of consumers, particularly dietary supplements that contain undeclared prescription drug ingredients, is ongoing and apparently never ending. The FDA’s resources are not infinite, however, and can easily be overwhelmed by the prevalence of products such as these that make their way into the U.S. and to consumers through various means. Part of the FDA’s goal is to make consumers aware and, hopefully, reduce the chances for harmful, unapproved products to get into their hands, but with illegal dietary supplements, the game of Whack-A-Mole never seems to end.
