Nutrition

Urgent Alert: Major Recall on Popular Herbal Supplements Due to Undisclosed Drug Risks

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People across the United States often take supplements to boost their health, but it’s crucial to remember that the U.S. Food and Drug Administration (FDA) does not give pre-market approval for dietary supplements. Consequently, if safety issues surface, they typically arise after consumers have already had the chance to purchase and use the products. Currently, this situation is unfolding as two separate supplements are being recalled due to undisclosed drug ingredients.

The FDA recently disclosed a company announcement regarding the first of these supplement recalls. The announcement, made on July 15, concerns a voluntary recall by SoloVital.com, a California-based company, of all batches of its Umary Acido Hialuronica (Hyaluronic Acid) supplements. This product, promoted and sold for pain relief, is distributed nationwide via the company’s 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,” according to the recall notice.

“Products containing diclofenac and omeprazole cannot be marketed as dietary supplements.”

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It 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,” warns the FDA. There may also be harmful interactions with other medications, particularly if consumers use multiple products containing NSAIDs.

On the other hand, omeprazole is a proton pump inhibitor (PPI) typically used to treat stomach acid-related disorders. However, it “may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache,” according to the FDA. This surreptitious ingredient can potentially camouflage stomach problems and may negatively interact with other medications.

SoloVital is currently contacting its customers via email to arrange product returns. In the meantime, consumers who have the affected Umary supplements are being strongly advised to cease usage and return them to their original place of purchase.

Yet, there’s a second supplement of concern that might be in your household. Following closely on the heels of the Umary recall, the FDA released another company announcement about another supplement recall on July 16. This one concerns the voluntary recall of some Infla-650 Herbal Dietary Supplement Capsules by Guru Inc., a Georgia-based company.

These Infla-650 Herbal supplements were also found to contain hidden diclofenac. In addition, they also included undisclosed acetaminophen and phenylbutazone. This poses a significant risk to consumers due to the danger of unintentional acetaminophen overdose, especially if consumers are also taking other products containing acetaminophen.

“Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death,” according to the recall notice. Furthermore, the presence of phenylbutazone, an NSAID previously discontinued for human use in the U.S., is concerning due to its risk of causing potentially fatal injuries, specifically bone marrow toxicity.

The recalled Infla-650 supplements, marketed as an herbal dietary supplement for pain relief, were distributed nationwide and sold online. Like SoloVital, Guru Inc. has initiated communication with its distributors and customers for product return. Consumers are urged to stop use and return any recalled Infla-650 supplements to their place of purchase.

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