[9/5/2024] FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingredients not listed on the product label. FDA urges consumers taking these products to talk to their health care professional if they have any concerns.

These products might also be sold under variations of the name Umary and Amazy. They are promoted to treat pain and other conditions. These products are sold on various websites, including SoloVital, Main Products and Amazon, and in some retail stores.

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 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.

FDA laboratory testing found certain Umary and Amazy products contain the drug ingredients diclofenac and omeprazole, which are not listed on the product label. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs 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. Diclofenac also may interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Omeprazole is a proton pump inhibitor (PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea and headache. Omeprazole may also mask stomach issues such as erosions, ulcers and stomach cancer, and it can also interact with other medications.

The agency recently issued a warning letter to SoloVital for selling Umary. In July 2024, Main Products and SoloVital recalled Umary products.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at Medwatch; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The agency has seen an increase in fraudulent products marketed for pain that contain hidden ingredients. Consumers should use caution when considering purchasing these types of products as these products may be harmful.

The agency maintains a database of Health fraud products and encourages consumers to beware of Health fraud scams.