FDA recalls herbal supplement sold on Amazon after finding ‘serious and life-threatening’ ingredients
An herbal supplement sold on Amazon is being recalled after it was found to contain a substance also found in illegal drugs.
Infla-650 is a $55 “blend of ancient Indian herbs” sold nationwide, including on Amazon. It’s said to help soothe users’ joints and keep their bones healthy.
But routine testing by the FDA found the “supplements” were contaminated with three substances not listed on the label, including phenylbutazone, which was also banned in the US in the 1980s after it was linked to a series of deaths.
Swabs also showed the supplements contained acetaminophen, the active ingredient in the painkiller paracetamol, and Diclofenac, which is used in anti-inflammatory drugs. In high doses, these can also be fatal.
Infla-650 is a $55 “blend of ancient Indian herbs” sold nationwide that claims to soothe users’ joints and maintain healthy bones (product pictured above). It is now being recalled
Routine testing by the FDA found the products contaminated with three drugs, making them illegal to sell as supplements
The FDA has ordered a large recall of the product in the U.S., where it is sold in vitamin and supplement stores. There have been no reports of adverse reactions so far.
The agency said: ‘Use of the product poses a serious risk to consumers.
‘Infla-650 Herbal Dietary Supplement Capsules is a new, unapproved drug whose safety and efficacy have not been established and therefore it is subject to recall.’
Phenylbutazone can cause gastrointestinal bleeding and damage to the liver and kidneys. In severe cases, it can also stop the bone marrow from producing enough blood cells, which can lead to severe bleeding, infection, and death.
The drug was banned in the U.S. and U.K. after its Swiss manufacturer said in 1982 that it may have been linked to 1,182 deaths. Today, officials say it remains in the U.S. as an adulterant in street drugs.
The FDA also raised concerns that consumers using the product could inadvertently overdose on acetaminophen, putting them at risk for liver failure.
According to the agency, diclofenac increases the risk of heart attacks or strokes, as well as gastrointestinal bleeding and fatal perforation of the stomach lining.
The supplements claim to help reduce inflammation and relieve joint pain
They also said that the drugs in the supplement may interact with other medications patients are taking, leading to side effects.
It is not clear how much of each drug the supplement capsules contain, but it is believed to be very small amounts.
GURU INC, which marketed the product, is notifying distributors and customers about the recall by email.
The recalled products have lot number IN-032 and a best-before date of November 2027. They were shipped to retailers nationwide between March and June of this year.
The FDA is advising consumers who have the recalled product in their possession to immediately stop using it and return it to the store where it was purchased.
This comes after the FDA recalled THC-laced gummies and candies sold in multiple states after people were hospitalized and a “possible” death was linked to the treats.
A total of 39 illnesses have been reported in people who ate Diamond Shruumz candies.
Symptoms included seizures, involuntary muscle contractions, nausea and vomiting, and loss of consciousness.