Juice recalled over potential harmful bacteria contamination has been issued a Class I risk warning by the Food and Drug Administration (FDA).

Walker’s Wine Juice LLC of Forestville, New York, recalled its pumpkin juice on March 28 due to possible contamination with Clostridium botulinum, a bacterium that can cause botulism, a serious illness that affects the nervous system.

The product was distributed in 12 states, including Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania and Wisconsin.

Newsweek has contacted Walker’s Wine Juice for comment.

Why It Matters

Botulism, a potentially fatal form of food poisoning caused by Clostridium botulinum, can cause a wide range of symptoms including general weakness, dizziness, double-vision and trouble with speaking or swallowing.

It can also cause difficulty in breathing, weakness of other muscles, abdominal distension and constipation.

According to the FDA, around 10 outbreaks of foodborne botulism occur annually in the U.S.

What To Know

The affected products were packaged in 2.5- and 5-gallon boxes, along with 30-, 60- and 275-gallon bulk containers.

All lots and codes of the product were included in the recall, and the FDA said that a total of 1,466 gallons of juice were affected. According to the FDA, the recall is still ongoing.

As of April 1, no illnesses had been reported, Walker’s Wine Juice said.

The FDA issued its Class I risk classification on April 222, meaning it is a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The potential contamination was discovered after inspectors from New York’s Department of Agriculture and Markets found that the pumpkin juice pH was too high for the “hot fill” process to be carried out effectively when being packaged.

The FDA said that is was subsequently determined that “no adequate kill step was used to address the possibility of microbiological hazards.”

What People Are Saying

The World Health Organization said on its website about botulism: “Foodborne botulism is a serious, potentially fatal disease. However, it is relatively rare. It is an intoxication usually caused by ingestion of potent neurotoxins, the botulinum toxins, formed in contaminated foods. Person to person transmission of botulism does not occur.”

The FDA wrote in a report on the bacteria: “A food may contain viable C. botulinum and still not be capable of causing botulism. If the organisms do not grow, no toxin is produced. Although many foods satisfy the nutritional requirements for the growth of C. botulinum, not all of them provide the necessary anaerobic conditions. Both nutritional and anaerobic requirements are supplied by many canned foods and by various meat and fish products. Refrigeration will not prevent growth and toxin formation by nonproteolytic strains unless the temperature is precisely controlled and kept below 3°C. Foods processed to prevent spoilage but not usually refrigerated are the most common vehicles of botulism.”

What Happens Next

Walker’s Wine Juice LLC has warned any consumers experiencing symptoms related to botulism to seek immediate medical attention.