The Food and Drug Administration issued an allergy alert Tuesday after HerbsForever LLC recalled 90 units of dietary supplements containing undeclared wheat that could trigger life-threatening allergic reactions in sensitive consumers.
HerbsForever LLC of Los Angeles, California, voluntarily recalled 45 units each of "Hingwastik Churna" and "Gastro Care" dietary supplements on Jan. 7, 2026, after discovering the products may contain undeclared wheat. The FDA alert warns that people with wheat allergies face serious or potentially fatal allergic reactions if they consume these products.
The recall affects a relatively small number of units but represents a serious public health concern for the estimated 1% of Americans who suffer from wheat allergies or celiac disease. Unlike wheat intolerance, wheat allergies can trigger anaphylaxis, a severe allergic reaction that can cause breathing difficulties, swelling, and cardiovascular collapse requiring immediate medical attention.
Dietary supplement recalls involving undeclared allergens have become increasingly common as the FDA intensifies oversight of the $50 billion supplement industry. Under federal law, manufacturers must clearly label all ingredients, including common allergens like wheat, milk, eggs, fish, shellfish, tree nuts, peanuts, and soybeans.
The recall highlights ongoing challenges in supplement manufacturing and quality control. Many dietary supplement companies source ingredients from multiple suppliers, creating potential for cross-contamination during production or packaging. The presence of undeclared wheat in these products suggests either inadequate ingredient screening or contamination during the manufacturing process.
HerbsForever LLC markets itself as specializing in traditional herbal remedies and Ayurvedic supplements. "Hingwastik Churna" is described as a digestive aid containing various herbs, while "Gastro Care" is marketed for gastrointestinal health. The company has not disclosed how wheat contamination occurred in these products or whether other items in their product line might be affected.
The FDA's enforcement action comes amid broader scrutiny of supplement industry practices. Unlike prescription medications, dietary supplements do not require pre-market approval from the FDA. However, manufacturers remain responsible for ensuring their products are safe and properly labeled before bringing them to market.
Consumers who have purchased these specific products are advised to stop using them immediately and contact their healthcare provider if they experience allergic reactions. Symptoms of wheat allergies can range from mild reactions like hives and digestive upset to severe anaphylactic shock requiring emergency treatment.
The agency has not indicated whether HerbsForever LLC faces additional regulatory action beyond the voluntary recall. Companies that fail to properly label allergens can face warning letters, product seizures, and in extreme cases, criminal prosecution. The FDA typically works with manufacturers to ensure recalled products are removed from commerce and consumers are properly notified.
This recall represents part of a broader pattern of allergen-related enforcement actions by the FDA. The agency has issued dozens of similar alerts in recent years as it has expanded efforts to ensure supplement manufacturers comply with allergen labeling requirements established under the Food Allergen Labeling and Consumer Protection Act.
Industry observers note that smaller supplement companies often lack the robust quality control systems employed by larger pharmaceutical manufacturers. This can lead to contamination issues that larger companies might catch through more extensive testing protocols.
Consumers with wheat allergies are advised to carefully read supplement labels and contact manufacturers directly about potential allergen content when information is unclear. The FDA recommends that individuals with food allergies consult healthcare providers before starting any new dietary supplement regimen.
HerbsForever LLC has not announced whether it plans to reformulate these products or implement additional quality control measures to prevent future contamination. The company also has not indicated whether it will conduct testing on other products in its line to ensure they do not contain undeclared allergens.
The FDA continues to investigate the scope of the contamination and whether additional regulatory action may be warranted. Consumers who experience adverse reactions after taking these supplements are encouraged to report them to the FDA's MedWatch program, which tracks safety issues with medical products and dietary supplements.