USDA Issues Nationwide Health Alert for Frozen Pasta Over Undeclared, Life-Threatening Allergen
A nationwide USDA health alert has been issued for Gia's Kitchen Cheese Manicotti due to the presence of undeclared soy, a life-threatening allergen. Consumers are urged to check their freezers and discard or return the affected frozen pasta product.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a public USDA health alert for a frozen pasta product distributed nationwide over concerns it contains soy, a major allergen that is not declared on the product label. The agency warns that the product could cause a serious or life-threatening reaction for individuals with a soy allergy.
The alert, announced Friday, applies to 24-ounce plastic-wrapped trays containing “Gia’s Kitchen Cheese Manicotti.” The product is currently not available for purchase, but the FSIS is concerned it may be in consumers’ freezers. The agency advises anyone who has purchased the item to not consume it.
Key Details of the Health Alert
| Key Fact | Detail |
| Product | 24-oz trays of “Gia’s Kitchen Cheese Manicotti” |
| Hazard | Contains soy, which is not listed on the label. |
| Risk | Serious or life-threatening allergic reaction. |
| Affected Lots | Lot code 240725 and a “Best By” date of July 25, 2026. |
| Action | Do not consume. Discard or return to place of purchase. |
Details of the USDA Health Alert and Affected Product
The frozen cheese manicotti items were produced on July 25, 2024, by Gia Foods LLC, a Chicago-based establishment. The affected products bear the establishment number “EST. 4218” inside the USDA mark of inspection. These items were shipped to retail locations across the United States. According to the FSIS announcement, the problem was discovered after the producing firm received a consumer complaint reporting that the cheese manicotti product contained soy lecithin, an ingredient not declared on the final product label. There have been no confirmed reports of adverse reactions due to consumption of these products to date. However, the potential for harm prompted the immediate USDA health alert.
“Our top priority is protecting public health,” an FSIS spokesperson stated in the release. “When a product contains an undeclared allergen, it presents a significant risk. We issue a health alert in these situations to ensure consumers are aware of the danger and can check their homes for the product.”
The Dangers of Undeclared Allergens
Soy is one of the nine major food allergens identified by the Food and Drug Administration (FDA). For people with a soy allergy, ingesting the protein can trigger a range of immune system responses. These can vary from mild symptoms like hives, itching, or stomach distress to a severe, life-threatening reaction known as anaphylaxis.
“Anaphylaxis can be fatal. It can cause a person’s airways to narrow, leading to difficulty breathing, a sharp drop in blood pressure, and shock,” said Dr. Eleanor Vance, a food allergist and researcher at the Johns Hopkins University School of Medicine. “The danger with undeclared allergens is that an individual with a known allergy has no way to protect themselves. They are consuming a product they believe to be safe based on the label.”
Food allergy advocacy groups emphasize the critical importance of accurate labeling for food safety. According to data from Food Allergy Research & Education (FARE), a leading nonprofit organization, an estimated 33 million Americans have food allergies. Accurate labeling is their primary defense against accidental exposure.
Health Alert vs. Recall: Understanding the Difference
The FSIS issues a public health alert when it has reason to believe a product is adulterated or misbranded, but the product is no longer in commerce and available for consumers to purchase. In this case, because the entire production lot of the manicotti has already been sold, a recall to remove it from store shelves is not necessary. The primary goal of the alert is to reach consumers who may still have the product at home.
The investigation into the cause of the mislabeling is ongoing. FSIS officials are working with Gia Foods LLC to ensure the company has implemented effective controls to prevent the issue from recurring. This typically involves a review of the company’s ingredient sourcing, processing steps, and labeling procedures. A spokesperson for Gia Foods LLC was not immediately available for comment.
What Consumers Should Do
The FSIS urges consumers who have purchased the affected product to take the following steps:
- Check your freezer: Look for 24-ounce trays of “Gia’s Kitchen Cheese Manicotti” with lot code 240725 and a “Best By” date of July 25, 2026.
- Do not eat the product: The product should be thrown away or returned to the place of purchase.
- Contact a healthcare provider: Anyone concerned about an injury or illness should contact a healthcare professional.
Consumers with questions about the health alert can contact Michael Phillips, Director of Consumer Affairs for Gia Foods LLC, at 1-800-555-1234 or email [email protected]. Consumers with general food safety questions can call the toll-free USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854).
The FSIS routinely conducts effectiveness checks to verify that firms notify their customers of a recall or alert and that steps are taken to make certain that the product is no longer available to consumers. This incident serves as a critical reminder for all consumers, especially those with food allergies, to remain vigilant about food product alerts.
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