Umary Acido Hialuronico recalled over undeclared diclofenac

Recall date

July 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SoloVital recalls Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

Recall number

D-0620-2024

FDA classification

Class I

Brand / firm

SoloVital

Sold / distributed

Nationwide within the United States

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.