Kuka Flex Forte 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 Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 4…

Recall number

D-0226-2024

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

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265