Dangerous Vitamin B12 Gummy Recall Issued Class I Warning by FDA for Undeclared Peanut Allergen

Undeclared Peanut Allergen Triggers Class I Recall for Popular Gummy Supplements

The U.S. Food and Drug Administration has issued a Class I recall, its highest risk level, for more than 40,000 bottles of Vitamin B12 supplement gummies manufactured by Vita Warehouse Corp. This serious alert stems from the possible presence of an undeclared peanut allergen, posing a life-threatening danger to individuals with peanut allergies. The products were sold across the country in major retailers including Aldi and Berkley Jensen, and include brands such as Welby, Berkley Jensen, and VitaGlobe. The affected gummies were distributed nationwide, raising significant health and legal concerns for consumers.

A Class I classification signals a high probability that the product could cause severe adverse health outcomes or death. While no allergic reactions had been reported as of mid-June 2025, the potential for anaphylaxis among unsuspecting consumers is significant. Anaphylaxis is a rapid-onset, life-threatening allergic reaction that requires immediate emergency intervention. Any consumer who suffered an allergic response after ingesting these products may have grounds for legal action.

The Hidden Dangers of Food Allergens in Supplements

Peanuts are one of the most dangerous and commonly known food allergens. Even trace amounts can cause a reaction in sensitive individuals. Under U.S. law, peanuts are considered one of nine major allergens that must be clearly disclosed on food and supplement labels. The law exists for a reason: accidental exposure can lead to devastating outcomes.

Symptoms of a peanut allergy reaction may include hives, facial swelling, tightness in the chest, wheezing, shortness of breath, rapid heartbeat, vomiting, and a drop in blood pressure. Anaphylaxis can result in airway obstruction, shock, and death if not treated immediately with epinephrine. Every three minutes, someone in the United States visits the emergency room due to food-induced allergic reactions. The risk posed by an undeclared allergen in a dietary supplement is not theoretical—it can be fatal.

The legal duty to disclose allergens on product labeling is clear. When manufacturers fail to adhere to these requirements, they put lives at risk. Retailers and distributors also have an obligation to ensure the safety of the products they sell. Consumers harmed by this oversight may be entitled to file a claim for damages including medical costs, lost wages, emotional distress, and in some cases, punitive damages for gross negligence.

Which Products Were Recalled and Where They Were Sold

The recall applies to three brands of Vitamin B12 supplement gummies manufactured by Vita Warehouse Corp. All products involved share the same lot number, 248046601, and expiration date of 10/2026. The specific products are:

• Welby Vitamin B12 Energy Support 1000 mcg, 140 gummies (UPC 4099100290868)
• Berkley Jensen Vitamin B12 1000 mcg, 250 gummies (UPC 888670132487)
• VitaGlobe Vitamin B12 Extra Strength, 60 gummies (UPC 850005214670)

These products were distributed and sold nationwide, both in-store and online. Primary retailers include Aldi and Berkley Jensen, but third-party online platforms may have also sold the supplements. Consumers who purchased any of the affected items should immediately stop using them and return the product for a full refund. Those who are allergic to peanuts are particularly at risk and should seek medical evaluation if they consumed these products.

Despite internal testing by Vita Warehouse Corp. indicating no detectable peanuts, the recall was initiated after independent testing by Aldi revealed potential contamination. This shows that even when companies claim compliance, the margin for error is too high when lives are on the line.

Understanding the Legal Implications of Class I Recalls

A Class I recall carries the most severe legal consequences because it reflects the FDA’s determination that use of the product could lead to serious injury or death. Manufacturers, importers, and distributors involved in the supply chain may be held legally responsible if consumers suffer harm due to their negligence.

Personal injury law allows those affected by dangerous or defective products to pursue compensation for:

• Emergency medical care and hospitalization
• Prescription medication and follow-up treatment
• Lost income during recovery
• Permanent disability or long-term allergic complications
• Pain and emotional distress

If a consumer dies due to an allergic reaction from an undeclared allergen, surviving family members may also file a wrongful death claim. These cases can hold negligent companies accountable and secure damages for funeral expenses, loss of companionship, and future income losses.

Victims should know that these claims are not limited to the manufacturer alone. Retailers and distributors who failed to verify the safety and labeling of products they sold may also be liable.

Why Proper Labeling and Allergen Warnings Matter

Food labeling is not just a technical requirement—it is a matter of public safety. The FDA mandates allergen disclosures under the Food Allergen Labeling and Consumer Protection Act (FALCPA), which requires that any food containing a major allergen must clearly list it in the ingredient list and a separate “Contains” statement. Failure to comply with these rules can result in contaminated products slipping into consumer hands.

Manufacturers have a legal and ethical obligation to conduct regular testing, maintain clean production facilities, and ensure that cross-contamination does not occur during manufacturing or packaging. Recalls often expose systemic weaknesses in these safeguards.

When companies cut corners or fail to follow allergen labeling protocols, they create unnecessary risks for vulnerable consumers. A recall is a reactive measure; the law allows victims to take proactive legal steps when their health has already been put in jeopardy.

What You Should Do If You Consumed a Recalled Gummy

If you or a loved one consumed a Vitamin B12 supplement gummy from the recalled lot and have a peanut allergy, take the following steps immediately:

1. Seek medical attention even if symptoms seem mild. Reactions can worsen quickly.
2. Save the bottle and packaging including the lot number, expiration date, and UPC.
3. Take photos of the product and any visible symptoms.
4. Keep receipts or order confirmations if you purchased the item online.
5. Consult a personal injury attorney to learn about your legal options.

Acting quickly is critical. Personal injury and product liability claims have strict time limits known as statutes of limitations, which vary by state. Delaying a claim could impact your ability to recover damages.

Contact Parker Waichman LLP For a Free Case Review

If you or someone you care about suffered a severe allergic reaction after consuming recalled Vitamin B12 gummies, Parker Waichman LLP is here to help. Our national product liability law firm is committed to fighting for victims harmed by mislabeled and dangerous consumer products. We offer free consultations and are available to review your case and explain your legal rights. Don’t wait—call 1-800-YOUR-LAWYER (1-800-968-7529) now to speak with a product injury attorney and find out if you may be eligible for compensation.