FDA Recalls Unavy Ácido Hialurónico Supplement for Hidden Drug Ingredients

The US Food and Drug Administration (FDA) has announced a voluntary recall of UNAVY Ácido Hialurónico, a dietary supplement packaged as 30-count bottles of 850 mg caplets. The product, distributed by EREN NATURAL S.A. DE C.V. in Zapopan, Jalisco, Mexico, and sold online nationwide in the US, has been flagged for containing undeclared pharmaceutical ingredients, specifically dexamethasone, diclofenac, and omeprazole. These compounds are not listed on the product label and require an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to be legally marketed in the US.

The recall is firm-initiated and remains ongoing under FDA oversight. Although the agency has not yet classified the recall, all lots of the product have been affected. Approximately 1342 bottles are subject to this action. The recalling firm, Umary-USA.com, based in Nogales, Arizona, alerted the public via a press release on May 21, 2025. The presence of undeclared corticosteroid (dexamethasone), NSAID (diclofenac), and a proton pump inhibitor (omeprazole) raises serious health concerns, especially for consumers with allergies, pre-existing conditions, or those taking interacting medications.

While Unavy Ácido Hialurónico is promoted as a supplement, its inclusion of potent pharmaceuticals alters its risk profile significantly. Dexamethasone can suppress the immune system, diclofenac can cause gastrointestinal or cardiovascular side effects, and omeprazole alters gastric acidity, potentially masking underlying conditions. Pharmacists should be alert to patient use of such unapproved supplements, as this case underscores the critical need for vigilance regarding imported or internet-sold products lacking FDA approval.