Reumo Flex caplets recalled over undeclared diclofenac

Recall date

October 20, 2023

Source

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

Official notice title

Botanical Be recalls Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 C…

Recall number

D-0225-2024

FDA classification

Class I

Brand / firm

Botanical Be

Sold / distributed

USA Nationwide

Why it was recalled

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

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

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598