Safety Alerts and Products Recalls > Products found to contain undeclared medicines

Products found to contain undeclared medicines   The United States: UMARY- USA.COM issues voluntary nationwide recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets due to the presence of undeclared drug ingredients dexamethasone, diclofenac and omeprazole   The United States Food and Drug Administration (FDA) announces that UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg), to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug ingredients Diclofenac, Dexamethasone and Omeprazole. Products containing diclofenac, dexamethasone or omeprazole cannot be marketed as dietary supplements. UNAVY ÁCIDO HIALURÓNICO and UMOVY ÁCIDO HIALURÓNICO are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall. 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. Consumption of undeclared dexamethasone, diclofenac, and omeprazole can also interact with other medications and cause serious side effects. Umary- usa.com has not received any reports of adverse events related to this recall. These products are marketed as dietary supplements for joint pain and arthritis. Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/umary-usacom-issues-voluntary-nationwide-recall-unavy-acido-hialuronico-caplets-and-umovy-acido In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 16 May 2025. Ends/Friday, May 23, 2025 Issued at HKT 16:00