FDA warns against use of tainted Umary and Amazy products
“FDA has received an increase in adverse event reports with the use of Umary products since the agency issued a warning in June 2024,” the FDA noted. “The adverse event reports are consistent with known common adverse reactions such as gastrointestinal, cardiovascular and serious skin reactions associated with the drug ingredients found in Umary.”
These prescription drug ingredients, which are not listed on label, include diclofenac and omeprazole, as confirmed by FDA laboratory testing of certain Umary and Amazy products.
Delistings and recalls
According to the warning, the products identified are promoted to treat pain and other conditions and may be potentially marketed under variations of the names Umary and Amazy.
FDA reported that they were being sold on websites including SoloVital, Main Products and Amazon, as well as in some retail stores.
The agency’s Center for Drug Evaluation and Research (CDER) recently issued a warning letter to SoloVital, a San Diego-area company that markets “Mexican supplements, natural remedies and more.” The site has since posted a red “Click here to read important health notice from the FDA regarding Umary Acido Hialuronico” banner at the top of its website and no longer lists the product for sale.
In July 2024, Main Products and SoloVital voluntarily issued recalls for Umary that read: “Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.” Both companies agreed to notify customers by email and arrange for the return of all recalled products.
NutraIngredients-USA contacted the number listed on the umary.shop website, which connected to an Amazon prep and fulfillment center in Barrie, Ontario. The representative could not confirm or deny if the center is still fulfilling orders for its client, but a search for Umary and Amazy on Amazon.com did not return active sellers pages. Amazon did not respond to a request for comment prior to publication.
Umary in Canada
The Canadian government issued its first public advisory on Umary-branded hyaluronic acid in May, alerting consumers to potential serious health risks associated with the tainted product.
“This product, which is labelled in Spanish and does not have a Natural Product Number (NPN) on the label, is not authorized for sale in Canada but is being promoted and sold to consumers in Canada on various online platforms,” the advisory read. “Health Canada will continue to work with the identified online platforms to stop the advertising and sale of this unauthorized product.”
This advisory was issued not long after a Manitoba woman reported experiencing serious adverse effects from taking an 850 mg Umary pill once and sometimes twice a day to manage her walking pain.
While at first the rapid pain-numbing effects appeared miraculous, she became alarmed after suffering an episode that included shortness of breath, severe chest pain, leg rashes and lip blisters that sent her to the emergency room. Testing through a Vancouver drug testing organization revealed that 40% to 45% of the pill was actually diclofenac and at two to four times the recommended daily dosage.
At the time, local CTV News Channel reported that Umary said that it operated strictly within the current legal and regulatory frameworks established by the Mexican authorities and that it did not sell products in Canada.
"Therefore, any product labeled under our brand in Canada is not related to our company, and we cannot guarantee its authenticity or quality," the company responded in a statement shared with the news outlet. "We are not responsible for products that may be sold in that country under our brand without our consent, which could be counterfeit."
On Aug. 27, Health Canada updated the advisory after testing a variation labeled as Umary USA Hyaluronic Acid, finding it adulterated with steroidal prescription drug dexamethasone in addition to diclofenac and omeprazole.
Adverse events and health fraud products
The FDA requested that health care professionals and consumers report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
In its statement, the agency also noted that it has seen an increase in fraudulent products marketed for pain that contain hidden ingredients and encourages consumers to consult its database of health fraud products.
