(CNN) – The Food and Drug Administration has applied its highest-risk warning to a recent recall of frozen berries sold at Publix grocery stores.

The recall for GreenWise-brand organic blueberries was initiated in early July.

Later that month, the recall expanded to include GreenWise frozen mixed berries.

On Tuesday, the FDA categorized the recall as Tier 1.

The agency said the products have been linked to a multistate outbreak of E. coli.

According to the agency’s update on July 30, 12 people had been sickened and four hospitalized.

The affected products were sold in Publix locations across eight states and have been removed from shelves.

However, some shoppers may still have them in their freezers and are advised to return or throw them away.

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