Recall Issued: “Natural” Supplements from Botanical-Be May Cause Death

An urgent recall of several Botanical-Be supplements has been issued by the FDA after the presence of an undeclared drug was brought to light.  The supplements, marketed as a treatment for pain relief and inflammation, contain Diclofenac. While Diclofenac is commonly found in arthritis pain relief medication, such as Voltaren gel, the inadvertent use of Diclofenac can cause serious health outcomes for some patients. In fact, the FDA has been warning consumers about these supplements for over a year now.

April, 2022

The FDA warned consumers not to purchase products sold under the name “Artri” or “Ortiga” due to potentially active hidden ingredients. During inspections, the FDA noted Dexamethasone, Diclofenac Sodium, and Methocarbamol in the supplements. These drugs can be deadly when taken unknowingly by patients with certain conditions.

October, 2022

The FDA issued warning letters to retailers who continued to distribute the dangerous supplements, including Walmart, Amazon, and Latin Foods Market.

July, 2023

By this time, the FDA had received more than 30 reports of consumers experiencing negative and harmful health outcomes as a result of using Artri and Ortiga supplements. Some of the life-threatening conditions included liver toxicity, gastrointestinal bleeding, sudden weight gain, adrenal dysfunction, and high blood glucose levels.

After the FDA issued a notice warning consumers of Botanical-Be’s “natural” supplements, a woman in Milwaukee unknowingly continued using the supplements and was hospitalized after their use caused Congestive Heart Failure.

SUMMARY

Date of Recall:

Announced: October 22, 2023

Public Notification: October 23, 2023

Name(s) of Drug:

Artri King

Kuka Flex

Reumo Flex

Company Name:

Botanical-Be

Drug Indication:

Pain

Inflammation

Product Description

Botanical-Be supplements are distributed nationwide through online retailers such as Amazon.com, Walmart.com, and Latin Foods Market.

Reason for Recall

Products marketed as “natural” are not always safe. We have reported on several recalls and warnings involving supplements containing undeclared substances that can cause serious health outcomes.

The supplements listed in this recall contain an undeclared drug, Diclofenac.

Impacts

Consumers who continue to take the supplements are at a high risk of adverse health outcomes.

• Consumers who are allergic to Diclofenac or its ingredients may experience anaphylactic reactions that can lead to death.
• Consumers who regularly take other NSAID pain relievers such as Aspirin, Ibuprofen, or Naproxen are at a high risk of overdosing on the medication, an emergency situation that could lead to death.
• Consumers who take anticoagulants, such as Warfarin, regularly are at a high risk of bleeding episodes when used in conjunction with these supplements. This outcome could also lead to death.

Lot Information

Consumers should locate their supplement and compare UPC, lot numbers, and expiration dates with the chart below. If you find your UPC number, lot number, and expiration date on the chart below, your supplement is affected by the recall, and you must take additional steps to take part in recall procedures.

Product Description	UPC	Lot Number	Expiration Date
Artri King, 100 Capsules	All	35421	December 19, 2025
Kuka Flex, 30 Capsules	0736640810265	All	December 12, 2024
Reumo Flex, 30 Capsules	All	All	October 20, 2024

FDA.gov

Have you found that your supplement is part of the recall? Here’s what you should do:

Consumers

1. Call your doctor right away and notify them of your involvement.
2. Monitor your health for any adverse symptoms. Notify your physician if any concerns are noted.
3. Consumers may contact Botanical-Be at (915) 412-6237. They are available Mon-Fri from 8:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at botanical-.be@gmail.com.
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Botanical-Be at (915) 412-6237, or you can utilize botanical-.be@gmail.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Botanical-Be at (915) 412-6237, or you can utilize botanical-.be@gmail.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!