A Nationwide Recall on a Diet Supplement Was Just Updated

Supplements have become a more mainstream way to get nutrients that help make up for what the American diet often doesn’t deliver—but supplements often go untested and under-regulated, falling short of their hype or even causing more harm than good.

In July, one particular pill, Infla-650 Herbal Dietary Supplement, was widely recalled by the US Food and Drug Administration (FDA) for being tainted with three potentially harmful drugs that went unlisted on the label.

Infla-650 appears to have been sold on Amazon, as well as some independent vitamin and wellness sites, though at the time of this publication the Amazon page appears to have been taken down. The available product label we found says the product was “100% natural,” formulated to “promote a healthy muscular response” and “maintain a healthy musculoskeletal system.”

Today, the FDA has updated its notice by designating the recall as “Class II.” Within its three-tiered system, which is designed to indicate the degree of health hazard associated with a recall, Class II indicates “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The three undeclared substances reported within the supplements—acetaminophen, diclofenac and phenylbutazone—appear to be cause for alarm for some consumers. In the FDA’s initial recall notice, the agency stated that the alleged presence of these medications disqualifies the product from being marketed as a supplement at all, and that the product “poses a serious threat to consumers.”

Each of the undisclosed ingredients comes with its own specific risk. For instance, the presence of acetaminophen—the generic name for the pain reliever Tylenol—could result in unintentional overdose, the FDA warns. “Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases,” the authority wrote in July.

Diclofenac, another medication discovered in the supplement, is a non-steroidal anti-inflammatory drug (NSAID) which has the potential to interact with other medications, especially other NSAIDs. The Cleveland Clinic lists aspirin, ibuprofen, and naproxen sodium (generic for Aleve and other name brands) as examples of NSAIDs. The FDA warns that it can increase the risk of cardiovascular events including heart attack and stroke, and gastrointestinal problems, including “bleeding, ulceration, and fatal perforation of the stomach and intestines.” Many doctors would also not advise taking an NSAID and acetaminophen together.

But perhaps most troubling in Infla-650 was the discovery of phenylbutazone, another NSAID that has been banned for human use in the United States and United Kingdom. The FDA notes that it was discontinued “due to the risk of serious and life-threatening injuries. The most serious and life-threatening injury associated with phenylbutazone treatment is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells, and/or platelets.”

None of these substances are listed among the ingredients, which are instead said to include ashwaganda and other exotic herbs.

The supplements, distributed by Guru Inc. based in Lilburn, Georgia and reportedly manufactured in India, were packaged in silver, 700-milligram (mg) pouches containing 60 capsules each. The affected products bear the lot number IN-032 and a November 2027 expiration date. Neither the recall notice nor the update states how many units of the product were distributed, but both note that the product was sold nationwide to retailers and via the internet, including on Amazon.

In March 2023 it was said Infla-650 was recently featured on the episode 2116 of the podcast The Joe Rogan Experience, when Rogan’s guest, the actor Kevin James, promoted it for pain relief. The show has over 11 million YouTube subscribers, and is one of the highest ranked shows on Apple Podcasts.

To date, the distributor of Infla-650 says it has not received any reports of illness related to this recall. If you have taken the tainted supplements and believe you may be experiencing side effects, let your doctor or medical provider know. Discontinue use of the product, and discard or return it to your place of purchase.

For more information on the recall or getting a refund, you can contact Guru Inc. by phone at (470) 536-9800 (Monday to Friday, 9:00 AM to 5:00 PM EST) or by email at [email protected].

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