Recalled Olive Oil Assigned FDA Risk Alert

A total of two flavors of 108 bottles of Lotsa Pasta International Food Shop Infused Olive Oil were withdrawn and classified by the FDA.

Juliette Fairley

Published: 12/10/2025, 1:48:08 PM EST

Recalled Olive Oil Assigned FDA Risk Alert — Olive oil drops from green olive berry close up, macro shot. Fresh pressed extra virgin olive oil concept. (Adobe Stock)

The U.S. Food and Drug Administration (FDA) assigned its second-highest risk alert this week to two olive oil flavors that are sold in Kentucky.

The potential for contamination with Clostridium botulinum led Hale Inc. of Louisville, Kentucky, to withdraw Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil packaged in 12-ounce glass bottles, according to an FDA enforcement report.

The product, manufactured without an approved process filed, has UPC 736211448415 printed on it.

The Basil Infused Olive Oil flavor was also recalled for the same reason, according to the FDA.

A total of 108 bottles of the two olive oil flavors have been withdrawn.

The U.S. Centers for Disease Control and Prevention (CDC) states on its website that contamination from Clostridium botulinum toxins can happen as a result of improper food processing.

Hale Inc. company leaders did not respond to requests for comment by the time of publication.

This week, the FDA designated the recall a Class 2 event, which is the federal government’s second-highest risk alert and is described on the FDA website as exposure to a product that may cause temporary or medically reversible adverse health consequences.

A Class 1 recall is defined as having a reasonable probability that the use of or exposure to will cause serious adverse health consequences or death, while a Class 3 event involves products that violate regulations but are unlikely to cause health problems, such as minor labeling errors.

The FDA describes Botulism as a potentially fatal form of food poisoning that can cause general weakness, dizziness, double-vision, and trouble speaking or swallowing, as well as breathing difficulty, muscle weakness, abdominal distension, and constipation.

Last month, similar botulism concerns led to the recall of three pasta sauces that were distributed in Connecticut and Massachusetts through regional supermarket chain Big Y and potentially other retailers.

First and Last Bakery, LLC of Hartford, Connecticut, voluntarily withdrew its Tomato & Basil Original Marinara Sauce, Meat Flavored Traditional Pasta Sauce, and Mildly Hot & Spicy Puttanesca Sauce, according to a Nov. 4 FDA advisory.

“The products were manufactured without an approved scheduled process or otherwise evaluated to determine if the process is adequate,” the FDA said at the time. “Failure to appropriately process acidified or low-acid canned foods can result in Clostridium botulinum toxin formation.”

The recalled condiments were packaged in 26 fluid ounce jars and sold between Sept. 22 and Oct. 28.