Protein powder recalled in 37 US states — FDA warns of most serious risk

The US Food and Drug Administration has issued a Class I recall for a protein powder distributed across 37 US states after discovering a serious labeling error involving an undeclared allergen.The recall applies to Genepro Whey 4th Generation Plasma Treated Protein, an unflavored supplement sold in 225-gram resealable bags. While the product’s packaging prominently claims it is “allergen free,” “lactose free,” and “dairy free,” the FDA determined that it may contain milk, a major food allergen that must be clearly disclosed under federal law.Because consumption could lead to “serious adverse health consequences or death” for individuals with a milk allergy, the agency classified the recall as Class I, its most severe category.

Product details consumers should check immediately

The recalled protein powder is manufactured and distributed by Genepro Protein, Inc., based in Cary, North Carolina. According to the FDA, the recall affects 250 bags of the product.Only packages with the following identifiers are included:Product: Genepro Whey 4th Generation Plasma Treated Protein (unflavored)Package size: 225 gramsUPC: 850053365126Lot code: 250214Best-by date: February 13, 2027Servings: 30 per bagConsumers who have this exact product are advised not to use it.

Why the labeling error matters

The recall is not related to contamination, spoilage, or manufacturing defects. Instead, it centers entirely on mislabeling, one of the most serious violations in food regulation when allergens are involved.Milk is classified as a major allergen, and even small, undisclosed amounts can trigger reactions ranging from hives and gastrointestinal distress to breathing difficulties and anaphylaxis. This risk is especially significant for consumers who relied on the product’s “dairy free” claims when purchasing it.While some whey proteins are highly filtered and contain very low levels of lactose, milk allergy is distinct from lactose intolerance. For people with a true milk allergy, exposure to milk proteins, even in trace amounts, can be dangerous.

Where the product was sold

The FDA says the protein powder was distributed in 37 states, covering much of the country. Affected states include:Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wyoming.