A U.S. Food and Drug Administration (FDA) notice said that a supplement company issued a voluntary recall of its tejocote root and Brazil seed products because they were found by an FDA inspection to contain a poisonous plant.
The notice said that ingestion of the plant, yellow oleander, can “adverse effects” in the cardiovascular, neurological, and gastrointestinal systems that can be severe or fatal.
The company, G.A. Mart, received a report of “gastrointestinal illness, including painful symptoms in conjunction with internal bleeding” in connection with the tejocote product, called TejoRoot. It has not received reports of adverse reports associated with its H&Natural Brazil Seed, according to the notice.
Those products were sold across the United States and over the internet via Amazon, Walmart, and H&Natural, the announcement said.
Both Brazil seed and tejocote root are often marketed as weight loss supplements.
Yellow oleander can cause symptoms such as nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more, according to the notice. And by itself, tejocote can cause some adverse side-effects, including stomach symptoms such as stomach pain, nausea, vomiting, and diarrhea, officials have said.
The recalled supplements can be identified with the H&Natural logo along with a number of descriptions that can be found on the FDA website. The recalled lots have expiration dates of March 2024 and May 2024.
Other Warnings
In January, the federal health agency issued a warning about tejocote, also known Mexican hawthorn, saying it may be adulterated after an analysis found the substance was substituted with yellow oleander.
Noting that yellow oleander is a “toxic substance of concern to public health officials,” the FDA added that “in other words, the tested products are labeled as tejocote but are actually toxic yellow oleander.”
In the notice, the FDA said it tested 18 samples of different tejocote supplement brands and found that they all contained yellow oleander.
“The FDA advises consumers who have taken any of these products of concern to contact their health care provider immediately,” the agency continued. “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.”
Any consumer who owns the products listed on the FDA website should stop using them and dispose of them, the FDA advised.
Consumers who have had adverse reactions with the product can send a report to the FDA’s MedWatch system.
A report issued by the U.S. Centers for Disease Control and Prevention found there were numerous instances of companies replacing tejocote root with yellow oleander.
“These readily available dietary supplements, upon testing, appeared to be mislabeled,” the report said. “Instead, they contained a toxic substance of concern to both clinicians and public health officials.”
This week, the FDA also issued a major recall of eye ointments due to a “lack of sterility assurance at the facility noted during an inspection” conducted by the FDA at a facility in India.
“For those patients who use these products, there is a potential risk of eye infections or related harm,” said the FDA. “These products are intended to be sterile.”
“Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the agency added.