The escalation follows an FDA remote inspection of the Chilean supplier, which found a second contaminated lot and left the firm's future shipments subject to import detention.
The U.S. Food and Drug Administration classified a recall of GreenWise Organic Whole Blueberries and Whole Mixed Berries as Class I on Tuesday, according to CBS News, which reviewed the agency's enforcement report.
Class I is the FDA's highest of three risk tiers, reserved for recalls where using the product carries a reasonable probability of serious health consequences or death.
An E. coli O145:H28 outbreak tied to the frozen products has sickened 12 people across two states.
Key Facts
- The FDA classified the Publix blueberry recall as Class I on August 18, its highest risk level.
- Twelve illnesses and four hospitalizations, a 33% rate, have been confirmed in Florida and Georgia.
- Chilean supplier Frutas y Hortalizas del Sur's shipments now face detention under FDA Import Alert 99-35.
The recall started small. Frutas y Hortalizas del Sur S.A., a frozen berry supplier based in San Carlos, Chile, pulled a single 10-ounce lot of GreenWise Organic IQF Blueberries on July 3.
Seven of the 9 patients interviewed, 78%, reported eating frozen blueberries, and five specifically named GreenWise products bought at Publix.
Publix expanded the recall on July 29 to cover all lots of four GreenWise products: two sizes each of Whole Blueberries and Whole Mixed Berries.
The retailer, which operates 1,413 stores, shipped the recalled berries to stores in:
- Alabama
- Florida
- Georgia
- Kentucky
- North Carolina
- South Carolina
- Tennessee
- Virginia
Publix said the products should be discarded or returned for a full refund.
How One Recalled Lot Became a Class I Warning
The jump from one lot to a Class I warning traces back to a facility check in Chile. As part of the outbreak investigation, the FDA conducted a remote regulatory assessment of Frutas y Hortalizas del Sur and collected the firm's food safety records.
The review found concerns about an additional lot of blueberries used in the other GreenWise products. Publix pulled those products as a result.
Per its recall notice, Frutas y Hortalizas del Sur called food safety "a top priority for Frutas y Hortalizas S.A."
The company added that it was investigating the source of the contamination. The firm has not disclosed what caused the E. coli finding.
FDA Restricts Future Shipments From the Chilean Supplier
The same Chilean assessment carries a consequence for the supplier's access to the U.S. market going forward. The FDA added Frutas y Hortalizas del Sur products to Import Alert 99-35.
The alert lets the agency detain future frozen blueberry shipments from the firm without a physical examination. The firm can only get off that list by submitting documentation showing it has fixed whatever caused the violation. That is not automatic.
An import alert works differently than a domestic recall. A recall pulls product already sitting on shelves. An import alert intercepts product at the port, before it enters the country.
The exporter can't resume normal shipments until it proves the underlying problem is resolved. For Frutas y Hortalizas del Sur, that means a stricter entry requirement into the U.S. market than the one in place in June.
Case Counts and the Status of the Investigation
The illnesses behind the recall started well before either company acted. Symptom onset dates for the 12 confirmed patients run from May 11 to June 5, 2026, nearly four weeks before the first recall on July 3.
The FDA and CDC are still investigating the source of the contamination and have not closed the case count.
The agency's guidance for consumers has not changed since July. Check freezers for any of the four recalled products.
If the original packaging is gone and the contents can't be identified, throw it out. E. coli O145:H28 symptoms typically begin within nine days of exposure. Severe cases can progress to hemolytic uremic syndrome, a kidney complication most common in young children and older adults.
