Supplement Pulled for Containing Undeclared Drug

The dietary supplement Kuka Flex Forte is being recalled after an analysis by the US Food and Drug Administration (FDA) identified undeclared diclofenac in Kuka Flex Forte and two other products. “Diclofenac is an approved nonsteroidal anti-inflammatory drug (NSAID),” recalling firm Botanical-Be announced in a statement dated November 7, 2023. “The presence of diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.”

According to the December 6, 2023, FDA Enforcement Report, the recall affects all Kuka Flex Forte caplets (UPC 0736640810265), which are packaged in 100-count bottles. The caplets were manufactured by Kukamonga, Guadalajara, Jalisco, Mexico, sold online, and distributed throughout the US.

Botanical-Be voluntarily initiated the recall October 20, 2023. The FDA has not yet issued a recall classification.

Kuka Flex Forte is marketed as a dietary supplement for the relief of pain and inflammation associated with arthritis.