C&A Naturistics, based in National City, California, has initiated a nationwide recall of its AK Forte tablets after U.S. Food and Drug Administration (FDA) testing revealed undeclared drug ingredients. The tablets, sold as a dietary supplement for joint pain and arthritis, were found to contain diclofenac, dexamethasone, and methocarbamol—ingredients that are not permitted in dietary supplements. This recall includes all lots of the product.

Undisclosed Drug Components Found

The primary concern in this recall is the presence of three unlisted pharmaceutical ingredients: diclofenac, dexamethasone, and methocarbamol. These drugs are typically used under prescription due to their potential risks and interactions.

Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), is commonly used to reduce inflammation and manage pain. However, its use is associated with severe side effects such as an increased risk of cardiovascular complications, including heart attacks and strokes. Diclofenac can also cause gastrointestinal damage, leading to bleeding, ulcers, and even perforation of the stomach or intestines. These risks increase when combined with other NSAID products that consumers may unknowingly use simultaneously.

Dexamethasone, another drug found in AK Forte, is a corticosteroid. It is typically prescribed for inflammatory conditions but can suppress the immune system. Long-term or high-dose corticosteroid use can lead to adrenal suppression, where the body’s natural hormone production slows down. Stopping corticosteroids abruptly may cause withdrawal symptoms that require professional medical guidance. Consumers using this product without knowing it contains dexamethasone may face significant health risks, especially when the drug interacts with other medications.

Methocarbamol, a muscle relaxant, can cause drowsiness, dizziness, and a drop in blood pressure. This drug impairs mental and physical functioning, making it dangerous for those who drive or operate heavy machinery. Methocarbamol also increases the risk of accidental injury due to its sedative effects.

The FDA warns that these hidden ingredients pose a serious risk to consumers, especially those with pre-existing health conditions or those taking medications that may interact with the undisclosed drugs. Consumers should be aware of these risks and consult their healthcare providers if they have used AK Forte tablets.

Product Details and Distribution

AK Forte tablets are sold as a joint pain and arthritis supplement. They are packaged in a distinctive box featuring a white, blue, red, and gold design with an AK logo and gold crown. The product contains 100 tablets and was distributed through various online platforms, including Ebay and Etsy.

Consumers who purchased this product are advised to immediately stop using it. Those currently using AK Forte should contact their healthcare providers to discuss the risks of continuing or stopping the use of the product. Sudden discontinuation of corticosteroids, like dexamethasone, can cause withdrawal symptoms, and only a licensed professional should guide the process. The FDA has provided resources on its website for consumers concerned about adrenal suppression and other risks associated with corticosteroid use.

C&A Naturistics is notifying distributors and customers of the recall. They are working on the logistics to facilitate the return or replacement of the affected products. The company has not yet received reports of adverse events, but consumers are urged to report any health issues to their healthcare providers.

Consumers are also encouraged to report any adverse reactions related to the use of AK Forte to the FDA’s MedWatch reporting system. This system allows the FDA to track potential health risks and take necessary action. The presence of unlisted pharmaceutical ingredients in dietary supplements has become a concerning issue, and consumer reports help regulatory agencies identify and mitigate these risks.

Health Risks and Precautions

This recall highlights the significant dangers posed by unlisted drug ingredients in over-the-counter supplements. Consumers using AK Forte are at risk of serious health complications due to the presence of diclofenac, dexamethasone, and methocarbamol. These drugs, typically prescribed by healthcare professionals, should not be taken without proper medical oversight.

Healthcare professionals strongly advise consumers to avoid using AK Forte tablets, especially if they are taking other medications. Drug interactions can amplify the side effects of the undeclared ingredients, increasing the likelihood of severe adverse reactions. Additionally, individuals with underlying health conditions, such as cardiovascular disease or gastrointestinal disorders, should be particularly cautious.

Consumers who have purchased this product can return it to the point of sale for a refund or safely dispose of it. The FDA continues to monitor the safety of dietary supplements and regularly issues warnings about tainted products. This recall emphasizes the importance of only purchasing supplements from reputable sources and checking for FDA alerts regarding product safety.