FDA Issues Warning About Certain Supplements Substituted with Toxic Yellow Oleander (January 2024)

What’s New

September 27, 2024

The FDA has added three additional products containing toxic yellow oleander to this Safety Alert. The complete list of products can be found in the chart below.

April 4, 2024

The FDA has completed analytical testing of an additional product which has similarly tested positive for yellow oleander. The FDA has received adverse event reports, including one report of a serious adverse event, for Green ELV Nutrition brand Elv Control Herbal Supplement (capsules). The product has been added to the table below.

March 12, 2024

The FDA continues to receive adverse event reports related to the products identified in this Safety Alert. The agency is reminding consumers to avoid these products because they contain toxic yellow oleander and can cause neurologic, gastrointestinal and cardiovascular adverse health effects that may be severe, or even fatal. The agency continues to communicate with firms selling these products. While a few have initiated voluntary recalls (please see the updates made to the table below), the FDA is concerned that products containing toxic yellow oleander remain on the marketplace. The FDA continues to evaluate additional regulatory pathways to remove all identified products from the marketplace.

The complete list of products can be found in the chart below.

Audience

All consumers

What is the problem?

FDA analysis has determined that certain dietary supplements labeled as tejocote (Crataegus mexicana) root or Brazil seed are adulterated because they were tested and found to be substituted with yellow oleander (Thevetia peruviana), a poisonous plant native to Mexico and Central America and a toxic substance of concern to public health officials. In other words, the tested products that were labeled as tejocote or Brazil seed are actually toxic yellow oleander.

Tested Products

As of 1/26/2024, the FDA tested as many as 18 samples, representing the products listed below, and found them to contain yellow oleander:

SELLING FIRM	BRAND	WEBSITE PURCHASED FROM	RECALL STATUS
Creativa Interiors, LLC/Privit Wellness, LLC	Primor Health Optimus Weight	Amazon.com (3rd party fulfillment)	Firm has not committed to a recall
Innovacion Natural, LLC	SdB Elite Salud da Belleza	Amazon.com (3rd party fulfillment)	FDA unable to contact firm
Innovacion Natural, LLC	Brazil Seed Semilla de Brazil	Amazon.com (this product was fulfilled by Amazon Fulfillment)	Amazon: Removed listings Seller: FDA unable to contact firm
World Green Nutrition Inc. / Alipotec	Green ELV Nutrition brand Elv Control Herbal Supplement (capsules)	Amazon.com Independent Distributor (Alipotec)	Recall Initiated
Alipotec South TX World Green Nutrition, Inc.	ALIPOTEC ELV Mexican Tejocote Root	alipotecus.com	Recall Initiated
Amazon.com	nwl NUTRA Mexican Tejocote Root	Amazon.com	Recall Initiated by seller
Global Mix Inc.	EVA NUTRITION Mexican Tejocote Root	Eva-nutrition.com	Recall Initiated
Sunset Sales +	ELV King All Natural Tejocote Root ELV King Tejocote Root Raiz de Tejocote	Amazon.com	Declined to recall, removed listings
ALIPOTEC RAIZ DE TEJOCOTE	ALIPOTEC Tejocote Root Dietary Supplement Pieces	alipotectejocote.com	FDA unable to contact firm
Natural Supplements, LLC	Science of ALPHA Mexican Tejocote Root	Tejocotemexican.com	Recall Initiated
H and Natural	H & Natural Tejo Root Raiz de Tejocote H & Natural Brazil Seed	Handnatural.com	Recall Initiated
Backstage CTC Seller	ALIPOTEC Tejocote Root Raiz de Tejocote	Amazon.com	Recall Initiated by seller
Amazon.com	ALIPOTEC Tejocote Root Dietary Supplement Pieces Nutraholics ELV Tejocote Root Dietary Supplement Pieces Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces ALIPOTEC Tejocote Root	Amazon.com	Declined to recall, removed listings
Global Mix, Inc.	Niwali Raiz de Tejocote Science of Alpha Mexican Tejocote Root	Etsy.com	Recall Initiated
Innovacion Natural, LLC	ALIPOTEC Tejocote Root Dietary Supplement Pieces	Innovacionnatural.com	FDA unable to contact firm
Pastor-Villareal, Inc.	Tejocotex Tejocote Root	Amazon.com	Declined to recall, removed listings

Recommendations for consumers

The FDA is advising consumers to stop using and dispose of these products.
The FDA advises consumers who have taken any of these products of concern to contact their health care provider immediately. Even if these products have not been used recently, consumers should still inform their health care provider about which product they took, so that an appropriate evaluation may be conducted.
Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products.
Contact your healthcare provider if you or someone in your care recently ingested these products and have health concerns.
Consumers can also contact the state poison control center.

Summary and Scope of the Problem

In September 2023, the Centers for Disease Control and Prevention published a report of several tejocote root products found to be substituted with toxic yellow oleander. Based on this report, the FDA initiated an investigation to sample and test additional tejocote root products. As of 1/26/2024, the FDA tested as many as 18 samples, representing the products listed above, and found them to contain yellow oleander.

Based on the FDA’s sampling and testing results thus far, the FDA is also concerned that other products marketed as tejocote root (including with other names such as Crataegus mexicana, Raiz de Tejocote, and Mexican Hawthorn) may contain yellow oleander. Consuming yellow oleander can cause severe adverse health effects and be potentially fatal.

Actions

The FDA is actively working with the third-party platforms where these products are sold.

The FDA’s investigation is ongoing, and the FDA will continue to provide information on any further actions as it becomes available. Products may be added to this advisory. The FDA is working to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging issues.

Who to Contact

To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.