Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning
A recall of thousands of bottles of supplement gummies has been issued the highest risk warning by the U.S. Food and Drug Administration (FDA).
Vita Warehouse Corp., based in New York, issued a voluntary recall for more than 40,000 bottles of Vitamin B12 supplements on June 12 because of the possible undeclared presence of peanut, a major food allergen.
The FDA subsequently issued is Class I risk classification on July 3.
Vita Warehouse Corp. issued a voluntary recall for more than 40,000 bottles of Vitamin B12 supplements on June 12 because of the possible undeclared presence of peanut.
Vita Warehouse Corp/FDA
Why It Matters
A Class I risk classification represents “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA.
Peanuts are one of the nine major food allergens as set out in law. The others are eggs, milk, fish, crustacean shellfish, tree nuts, wheat, sesame and soybeans.
The FDA warned that people who have an allergy or severe sensitivity to peanuts “run the risk of serious or life-threatening allergic reactions if they consume these products.”
Allergic reactions vary in severity from mild symptoms such as hives and lip swelling to life-threatening complications such as anaphylaxis that may include fatal respiratory problems.
What To Know
The products impacted by the recall include:
- Welby Vitamin B12 Energy Support 1000 mcg 140 gummies – UPC Code: 4099100290868 – lot number: 248046601 – expiration date: 10/2026
- Berkley Jensen Vitamin B12 1000 mcg 250 gummies – UPC Code: 888670132487 – lot number: 248046601 – expiration date: 10/2026
- VitaGlobe Vitamin B12 Extra Strength 60 gummies – UPC Code: 850005214670 – lot number: 248046601 – expiration date: 10/2026
The products were distributed nationwide at Aldi and Berkley Jensen stores, and online.
As of June 13, no illnesses or allergic reactions had been reported in connection with the products.
The recall was initiated after Aldi conducted routine testing that indicated a “potential presence of a peanut allergen,” according to the FDA.
“Although internal testing conducted by Vita Warehouse Corp. has verified the absence of peanuts in the product, the recall is being initiated out of an abundance of caution to ensure consumer safety and trust,” the recall notice said.
What People Are Saying
Vita Warehouse Corp. told Newsweek in a statement: “This recall was initiated out of an abundance of caution after one of our retail customers Aldi conducted routine testing on the product to verify allergen-related label claims. While their initial test indicated a potential presence of peanut, all third-party confirmatory testing commissioned by Vita Warehouse—including ELISA and PCR testing—showed no presence of peanuts in the product, its raw materials, or packaging components.
“We want to assure consumers that their health and safety remain our top priority, and we are fully cooperating with the FDA throughout this process.
“Consumers who purchased the affected lot are eligible for a full refund and are encouraged to provide the lot number and expiration date from the bottle, along with a photo of the product.”
The FDA, on its website: “People with food allergies should read labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food.”
Dr. Sebastian Lighvani, director of New York Allergy & Asthma PLLC, previously told Newsweek: “Every three minutes in the United States, someone ends up in an emergency room because of an allergic reaction after accidental ingestion of food. So even when we try hard, these reactions are happening. And if you look at the incidence of anaphylaxis, it has skyrocketed in the last five, 10, 20 years. And in the U.S., there’s like a 300 to 400 percent increase in the rates of anaphylaxis to foods.”
What Happens Next
The recall is listed as ongoing, according to the FDA.
Consumers who are allergic to peanuts and may have purchased the affected products are advised to return them to their place of purchase for a full refund or discard them immediately. Consumers who experience allergic reactions should seek medical attention immediately.
Update 08/07/2025 1 p.m. ET: This article was updated with comment from Vita Warehouse Corp.
