Millions of people across the nation take supplements to aid their health in one way or another. However, it's important to understand that the U.S. Food and Drug Administration (FDA) doesn't approve dietary supplements before they hit the market. So if concerns are present, it's usually only after you have the chance to buy them that regulators make a move—which is what is now happening with two supplements that are being recalled over hidden drug ingredients.
RELATED: Supplement Recalled Over "Poisonous Plant" Ingredient, FDA Warns.
The FDA shared a company announcement about the first supplement recall on July 15. According to the notice, California-based company SoloVital.com is "voluntarily recalling" all lots of its Umary Acido Hialuronica (Hyaluronic Acid) supplements.
"The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry," SoloVital states in its announcement, adding that the product was distributed nationwide through its online store.
The recall was ordered after an FDA laboratory analysis confirmed that the Umary supplements were tainted with two hidden drug ingredients: diclofenac and omeprazole.
"Products containing diclofenac and omeprazole cannot be marketed as dietary supplements," the notice explains. "Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall."
Diclofenac is a non-steroidal anti-inflammatory drug, or NSAID, which can "cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines," according to the FDA.
"This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products," the agency also notes.
Omeprazole, on the other hand, is a proton pump inhibitor, or PPI, that is used to treat stomach acid-related disorders. "PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache," the FDA says. "This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications."
SoloVital is contacting customers via email and working to arrange the return of all recalled products. In the meantime, consumers who have the affected Umary supplements are being urged to "stop using [them] and return [them] to place of purchase."
RELATED: Supplements Sold Nationwide Recalled Over Potentially Severe "Adverse Events."
But this is not the only concerning supplement you may have in your home. Just one day after the Umary recall, the FDA shared another company announcement on July 16 about a different supplement recall. According to this notice, Georgia-based company Guru Inc. is "voluntarily recalling" some of its Infla-650 Herbal Dietary Supplement Capsules.
Like the Umary supplements, the Infla-650 Herbal supplements were found to be tainted with diclofenac. But they also included two other hidden drug ingredients: acetaminophen and phenylbutazone.
As a result, the use of these Infla-650 Herbal supplements "poses a serious threat to consumers" because it could cause an unintentional overdose of acetaminophen—especially if consumers are taking them with other acetaminophen-containing products.
"Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death," the notice warns. "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 inclusion of phenylbutazone is also concerning because this is an NSAID that was discontinued for human use in the U.S. "due to the risk of serious and life-threatening injuries," according to the announcement.
"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," the recall states. "Certain types of bone marrow toxicity are reversible; however, in rare circumstances it can lead to death. Patients with anemia, low white or red blood cell count, or decreased blood platelets may be at a greater risk of death or serious injury."
Recalled Infla-650 Herbal supplements were marketed as an herbal dietary supplement meant for pain relief and packaged in 60-capsule silver-colored stand-up pouches with a green and white colored label.
The affected products were sent to retailers nationwide and sold online at NutraHerbUSA.cm and Nutra650.com. They also include the Lot No. IN-032 and have an expiration date of Nov. 2027.
"Guru Inc. is notifying its distributors and customers by email and is arranging for the return of all recalled products," the company adds. "Consumers and retailers that have Infla-650 which is being recalled should stop using/return to place of purchase."
