UMARY USA recalls caplets due to undeclared drugs

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Martin A Makary | U.S. Food and Drug Administration

UMARY USA recalls caplets due to undeclared drugs

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UMARY USA has initiated a voluntary recall of all lots of Unavy Ácido Hialurónico and Umovy Ácido Hialurónico caplets. This action follows an FDA laboratory analysis that revealed the presence of undeclared drug ingredients, including Diclofenac, Dexamethasone, and Omeprazole. These substances are not permitted in products marketed as dietary supplements.

The recalled products are packaged in containers holding 30 caplets each, with Unavy presented in a white plastic container and Umovy in a black plastic bottle. Both products have been distributed nationwide through umary-usa.com.

"Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions," the release states. It can impair infection-fighting abilities and cause other health issues such as high blood sugar levels and cardiovascular events. "Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs)," which may lead to serious adverse events when consumed without proper declaration. Omeprazole could mask stomach issues if taken unknowingly.

No reports of adverse reactions related to this recall have been received by UMARY USA so far. Consumers are advised to stop using these products immediately and consult healthcare providers for guidance on discontinuation.

The company is notifying distributors and customers via press release and email, arranging returns and refunds for all recalled items. Consumers can reach out to umary-usa.com at umaryusa2025@gmail.com for further information or report any adverse reactions directly to the FDA's MedWatch Adverse Event Reporting program.

This recall is conducted with the knowledge of the U.S. Food and Drug Administration.

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