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A total of 108 bottles across two different flavours of infused olive oil produced by Lotsa Pasta International Food Shop have been recalled and classified by the US Food and Drug Administration.
The US Food and Drug Administration (FDA) this week issued its second-highest risk alert for two flavours of olive oil sold in the state of Kentucky.
According to an enforcement report issued by the FDA, the possibility of contamination with Clostridium botulinum bacteria led Hale Inc., based in Louisville, Kentucky, to recall Lotsa Pasta International Food Shop's Roasted Garlic Infused Olive Oil, packaged in 12-ounce glass bottles.
The product, which was manufactured without a filed and approved manufacturing process, carries the Universal Product Code (UPC) number 736211448415 printed on it.
According to the FDA, the Basil Infused Olive Oil flavour was also recalled for the same reason.
A total of 108 bottles across both olive oil flavours were recalled.
The US Centers for Disease Control and Prevention notes on its website that contamination with Clostridium botulinum toxins can occur as a result of improper food processing.
Hale Inc.'s leadership had not responded to requests for comment by the time of publication.
The FDA this week classified this recall as a Class II event, the federal government's second-highest risk alert. The agency's website describes this classification as exposure to a product that may cause temporary or medically reversible adverse health consequences.
A Class I recall is defined as a reasonable probability that use of or exposure to a product will result in serious adverse health consequences or death, while Class III events involve products that violate regulations but are unlikely to cause health problems, such as minor labelling errors.
The FDA describes botulism as a potentially fatal form of food poisoning that can cause general weakness, dizziness, double vision, difficulty speaking or swallowing, as well as breathing difficulties, muscle weakness, abdominal bloating and constipation.
The possibility that consumers face high risks is a concern for experts such as Dr Vanessa Coffman, director of the Alliance to Stop Foodborne Illness, who says botulism is a pathogen that can lead to physical harm caused by neurotoxins.
Last month, similar botulism concerns led to the recall of three types of pasta sauce distributed in the states of Connecticut and Massachusetts through the regional chain Big Y and possibly other retailers. First and Last Bakery, LLC, based in Hartford, Connecticut, voluntarily recalled its Original Tomato Basil Marinara Sauce, Traditional Meat-Flavoured Pasta Sauce and Slightly Spicy Puttanesca Sauce, according to an FDA alert issued on 4 November 2025.
The FDA said at the time: "The products were manufactured without a filed scheduled process or were not otherwise evaluated to determine if the process was adequate. Failure to properly process acidified or low-acid canned foods can result in the formation of Clostridium botulinum toxin."
The recalled sauces were packaged in 26-fluid-ounce jars and sold between 22 September 2025 and 28 October 2025.
Source: NTD