FDA Alert: Nationwide recall of Unavy and Umovy supplements for undeclared drug ingredients

Summary:

Issued: May 21, 2025
Company Name: UMARY USA
Reason for Warning: Presence of undeclared active pharmaceutical ingredients
Drugs Involved: All lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg)
Risk Statement: Undeclared pharmaceutical ingredients can cause unanticipated side effects and adverse events that can harm or even kill patients.

Recall Announcement

The FDA has announced a voluntary nationwide recall of two dietary supplements sold exclusively online by www.umary-usa.com. Lab testing revealed that Unavy Ácido HIALURÓNICO and Umovy Ácido HIALURÓNICO contain undeclared active pharmaceutical ingredients: diclofenac, dexamethasone, and omeprazole. These ingredients cannot be marketed as dietary supplements. The FDA says these products are marketed for joint pain and arthritis.

Risk Statement:

  • Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, psychiatric problems, and lead to cardiovascular events. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland (a disorder in which the adrenal glands do not produce enough hormones) and adverse consequences can range from limited adverse consequences to death. Additionally, abrupt discontinuation can cause withdrawal symptoms.
  • Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses.
  • Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. Consumption of undeclared omeprazole may mask stomach issues such as erosions, ulcers, and stomach cancer.

None of these drugs were disclosed on the product labels, making them both unapproved and misbranded under the Federal Food, Drug, and Cosmetic Act. The products were distributed nationwide via the internet and are packaged in 30-caplet bottles. All lots and expiration dates are included in the recall. UMARY USA has not reported any adverse events at this time but is urging customers to discontinue use immediately and consult with their healthcare provider.

Product Photos

Consult the FDA alert for additional images.