Safety Report: Botanical-Be Dietary Supplements - recalled due to Undeclared Diclofenac, USA

United States

Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte, Capsules, Artri King, Capsules, and Reumo Flex, Capsules to the consumer level. FDA analysis has found these capsules, to be tainted with Diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), 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. These products were distributed nationwide via the internet. To date, Botanical-Be has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and are packaged as followed:
- Artri king distribute in the bottles with 100 capsules. Lot 35421, with an expiration date of December 19, 2025
- Kuka Flex distribute in the bottles with 30 capsules. All lots with an expiration date of December 12, 2024, and UPC code 0736640810265
- Reumo flex distribute in the boxes with 30 capsules. All lots with an expiration date of October 20, 2024.

Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Consumers in possession of these products should cease usage immediately and return them to the place of purchase.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Botanical-Be
Brand name: Multiple brands
Product recalled: Dietary Supplements with undeclared Diclofenac
Reason of the recall: Undeclared drug, Diclofenac
FDA Recall date: October 23, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/botanical-be-issues-voluntary-nationwide-recall-kuka-flex-forte-artri-king-and-reumo-flex-capsules