Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Nogales, AZ — UMARY USA has issued a voluntary nationwide recall of its joint pain relief supplements UNAVY Ácido Hialurónico and UMOVY Ácido Hialurónico, after U.S. Food and Drug Administration (FDA) testing revealed the presence of undeclared prescription drug ingredients: Dexamethasone, Diclofenac, and Omeprazole.
The recalled products, marketed as dietary supplements for joint pain and arthritis, were sold exclusively online via umary-usa.com. The recall affects all lots and expiration dates of both products.
Why the Recall?
FDA laboratory analysis found that both supplements contained:
- Dexamethasone: a powerful corticosteroid used to treat inflammation, which can cause serious side effects such as immune suppression, high blood sugar, muscle damage, and psychiatric issues. Long-term or high-dose use can suppress the adrenal glands, and sudden discontinuation may lead to withdrawal symptoms.
- Diclofenac: a nonsteroidal anti-inflammatory drug (NSAID) that may increase the risk of cardiovascular events, gastrointestinal bleeding, kidney problems, and allergic reactions — particularly dangerous for individuals already using NSAIDs or blood thinners.
- Omeprazole: a proton pump inhibitor that treats acid-related stomach disorders. Undeclared use may mask serious gastrointestinal conditions like ulcers or even stomach cancer.
The inclusion of these prescription-only ingredients violates FDA regulations, as dietary supplements are not permitted to contain unapproved drugs. The safety and efficacy of UNAVY and UMOVY have not been established, making them unapproved new drugs under federal law.
No Adverse Events Reported — Yet
While no adverse reactions have been reported as of May 21, the company urges customers to stop using the products immediately and consult their healthcare provider for safe discontinuation, particularly due to the presence of dexamethasone.
Product Description
- UNAVY Ácido Hialurónico: White plastic bottle with a black label and white/yellow text; contains 30 caplets (850 mg).
- UMOVY Ácido Hialurónico: Black bottle with a black label and white/blue text; contains 30 caplets (850 mg).
Both were distributed nationwide via online purchase.
What Consumers Should Do
- Stop using the recalled products immediately.
- Contact a healthcare professional to discuss safe discontinuation.
- Request a refund or return the product by contacting UMARY USA at umaryusa2025@gmail.com — available 24/7.
- Report any adverse health effects to the FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration. Consumers are encouraged to remain vigilant about the use of dietary supplements and report any suspicious or unapproved claims.
