A dietary supplement sold nationwide containing vitamin C as the primary named nutrient is under recall after the U.S. Food and Drug Administration (FDA) formally classified the action with an official risk level, weeks after the manufacturer first warned consumers about undeclared allergens.
Blueroot Health initially announced the recall in late March after internal testing identified undeclared allergens.
It later expanded the action on April 10 to include all products made from a different batch.
The FDA has now completed its review and classified the recall as a Class II action.
Newsweek has contacted Blueroot Health for comment via email.
What To Know
The recall involves Vital Nutrients Aller‑C dietary supplements, sold in 100‑count and 200‑count bottles, according to FDA enforcement records and company announcements.
Blueroot Health said the products might contain undeclared egg, soy and hazelnut, allergens that were not listed on the product labels.
People with allergies or severe sensitivities to these ingredients could face the risk of a serious or potentially life‑threatening allergic reaction if the supplements are consumed.
A total of 11,849 bottles are affected by the recall.
The supplements were distributed widely across 40 U.S. states: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.
According to the company, the recalled products were sold nationally through VitalNutrients.co and other online retailers, with distribution spanning September 2025 through March 2026.
The recall initially covered lots 25E04‑A and 25E04‑B, but Blueroot Health later expanded the recall to include all products made from lot 25E04.
The affected bottles have an expiration date of May 2027 and are packaged in white plastic bottles bearing the lot number on the side.
For 100‑count bottles, the affected Universal Product Codes are 693465524114 and 693465000083, linked to lots 25E04, 25E04‑A and 25E04‑B.
For 200‑count bottles, the UPCs are 693465524213 and 693465000090, associated with lot 25E04‑B.
Blueroot Health said the undeclared allergens were discovered during routine internal testing and were promptly reported to the FDA.
The company said no illnesses had been reported to date in connection with the product.
FDA records list the recall under recall number H‑0663‑2026, associated with Event ID 98663.
The recall was voluntarily initiated by the firm, and initial notifications were sent through multiple channels—including email, letters and news releases.
The recall was initiated on March 27. On April 15, the FDA formally classified the recall as Class II, assigning an official risk level.
The recall remains ongoing, and no termination date has been announced.
Consumers who purchased the affected supplements are advised to immediately discontinue use and return the product to Blueroot Health for a replacement.
What Is a Class II Recall?
The FDA uses a Class II recall designation when use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or when the probability of serious health effects is considered remote.
While not the agency’s most severe category, a Class II classification still reflects a meaningful safety concern—particularly when undeclared allergens are involved and consumers rely on labeling to avoid exposure.
