FDA Recalls 12 Herbal Supplements Over Hidden Drug Ingredients
On July 16, 2024, GURU INC. voluntarily recalled Infla-650 herbal dietary supplement capsules nationwide after the FDA found them tainted with undeclared drug ingredients, officials said. The FDA classified the recall as a safety action because the capsules contained acetaminophen, diclofenac, and phenylbutazone, posing significant health risks to consumers, particularly those with underlying conditions or taking interacting medications.
The presence of these undeclared pharmaceutical ingredients rendered the product an unapproved drug, prompting the agency to classify the recall as a safety action due to the significant health risks posed to consumers, particularly those with underlying medical conditions or who are taking other medications that may interact adversely, officials said. The FDA’s Human Foods Program issued a public warning on July 17, 2024, advising consumers to stop using Infla-650 capsules immediately.
The recalled Infla-650 capsules were found to contain acetaminophen, diclofenac, and phenylbutazone, none of which were declared on the product label, according to FDA testing results released July 16, 2024.
The FDA’s action against Infla-650 is part of a broader, multi-year enforcement effort targeting dietary and herbal supplements adulterated with prescription drugs or other hidden ingredients, records show. The agency maintains a Health Fraud Product Database that catalogs products found to contain undeclared pharmaceuticals, along with recall statuses and enforcement actions. This database includes numerous supplements marketed for pain relief, sexual enhancement, weight loss, and bodybuilding that have tested positive for hidden drugs, according to FDA notifications and health-fraud bulletins.
Other recent FDA investigations have uncovered undeclared nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam in herbal joint-pain supplements, as well as weight-loss products containing tianeptine, 1,4-DMAA, and aniracetam—ingredients not approved for dietary use due to cardiovascular and neurological risks, sources confirmed. Additionally, herbal powders and capsules from HerbsForever LLC, including Hingwastik Churna powder and Gastro Care capsules, were voluntarily recalled after FDA inspectors detected undeclared wheat, a known allergen that can trigger severe reactions in sensitive individuals.
The sexual-enhancement and energy supplement category has frequently been implicated in FDA recalls involving hidden drugs such as sildenafil, tadalafil, sulfoaildenafil, hydroxythiohomosildenafil, and related analogues. These substances are prescription-only erectile dysfunction drugs that pose dose-related risks, especially when consumers are unaware of their presence. In April 2017, Organic Herbal Supply Inc. voluntarily recalled multiple herbal male-enhancement products, including Uproar, Cummor, Zrect, Monkey Business, and others, after FDA analysis revealed undeclared tadalafil, sildenafil, and their analogues. The company also recalled Zrect for Women and LabidaMAX capsules following the detection of flibanserin, a prescription drug approved for hypoactive sexual desire disorder in women, officials said.
Health risks associated with these hidden ingredients are well-documented. Acetaminophen, when consumed unknowingly in combination with other acetaminophen-containing medications, can cause liver damage. Undeclared diclofenac and phenylbutazone increase the risk of gastrointestinal bleeding, kidney injury, cardiovascular events, and blood disorders, especially among people with arthritis, heart disease, or those on interacting therapies, according to FDA safety communications. Similarly, hidden meloxicam and other NSAIDs can lead to ulcers, bleeding, and renal impairment. Stimulant-like substances such as 1,4-DMAA and nootropics like aniracetam found in some herbal weight-loss supplements have been linked to severe cardiovascular and neurological events.
FDA public notifications emphasize that products containing undeclared pharmaceutical ingredients are unapproved drugs without established safety or efficacy for over-the-counter use. The agency advises consumers to discontinue use of recalled products and consult healthcare professionals if they experience adverse effects such as chest pain, shortness of breath, severe headaches, allergic reactions, or gastrointestinal bleeding. Healthcare providers and consumers are encouraged to report adverse events to support ongoing investigations and potential recalls.
FDA enforcement measures include voluntary recalls initiated by companies in coordination with the agency, as well as import alerts, warning letters, and other actions against firms that do not cooperate or have repeated violations. A study analyzing FDA data from 2007 to 2016 found that unapproved pharmaceutical ingredients were repeatedly detected in dietary supplements, particularly in sexual enhancement, weight-loss, and bodybuilding products. The most frequently found hidden drugs included sibutramine, sulfoaildenafil, sildenafil, tadalafil, hydroxythiohomosildenafil, and dimethylsildenafil.
The agency’s Health Fraud Product Database and category-specific notification pages provide consolidated lists of tainted supplements, including those marketed for pain, arthritis, sleep, skin, bodybuilding, and sexual enhancement. These resources aim to inform consumers and healthcare professionals about the risks posed by fraudulent products that circumvent drug-approval requirements. Recalls such as the one involving Infla-650 capsules illustrate the FDA’s ongoing efforts to protect public health from adulterated herbal supplements containing undisclosed pharmaceutical ingredients.
