California based C&A Naturistics is recalling all lots of AK Forte 400 mg tablets following an FDA study revealing the presence of undeclared medications, including diclofenac, dexamethasone, and methocarbamol. As AK Forte is an unapproved product, it cannot legally contain these active pharmaceutical ingredients or be marketed as a dietary supplement without proven safety and efficacy. The recall is a precautionary step to protect consumers from potential health risks associated with these hidden medications. C&A Naturistics is committed to ensuring customer safety and regulatory compliance by immediately removing the product from the market.

The drug regulator warns that using dexamethasone, a corticosteroid known for its anti-inflammatory properties, without medical supervision can be dangerous. Long-term corticosteroid use can depress the adrenal glands, damage the immune system, and cause muscle injuries, excessive blood sugar levels, and psychological issues. "The presence of undeclared dexamethasone in a dietary supplement is alarming because corticosteroids, especially when combined with other medications, can cause severe adverse effects," according to the FDA. Furthermore, rapid termination of corticosteroids can cause withdrawal symptoms, making their covert inclusion much more risky to unsuspecting customers.

FDA further informed that Diclofenac, a routinely used nonsteroidal anti-inflammatory medication (NSAID) to treat pain and inflammation, is the second undeclared ingredient in AK Forte. However, NSAIDs have well-documented side effects, including an increased risk of cardiovascular events, including heart attacks and strokes. Furthermore, NSAIDs can induce serious gastrointestinal problems such as stomach ulcers, bleeding, and even deadly intestinal perforations. The FDA warned that "hidden NSAID ingredients can interact with other medications, increasing the risk of serious side effects." Consumers who unwittingly consume numerous NSAID-containing products are at a heightened risk of adverse outcomes."

The third ingredient, methocarbamol, is a muscle relaxant that may cause dizziness, drowsiness, and low blood pressure. Methocarbamol can also impair cognitive and physical capacities, making activities like driving or operating machinery more dangerous. Serious safety concerns arise from the use of this medicine in a dietary supplement product. The FDA emphasised that the sedative effects of methocarbamol could pose a risk in settings that require full mental and physical function, particularly for consumers who may not be aware of these side effects.

C&A Naturistics is voluntarily recalling all lots of AK Forte as a precautionary measure, despite the absence of any reports of adverse occurrences. The FDA advises consumers to immediately stop using the product and seek advice from a healthcare practitioner, particularly if they are taking other medications or have pre-existing health issues that the undisclosed chemicals could exacerbate.

This incident underscores the continuous problem of ensuring that dietary supplements do not include hidden prescription substances that could pose serious health hazards. The FDA emphasises the necessity of regulatory control in preventing unapproved medications from reaching consumers via mislabeled products. An FDA representative stated, "We must carefully monitor the safety and efficacy of dietary supplements, and we cannot tolerate undeclared pharmaceutical ingredients."

The FDA 's MedWatch Adverse Event Reporting Program encourages consumers to report any adverse reactions or quality issues with AK Forte.