Toothpaste is meant to keep bacteria at bay, but an inspection from the Food and Drug Administration found that water contaminated with dangerous bacteria was used to manufacture batches of Colgate-Palmolive's Tom’s of Maine toothpaste. A "mold-like substance" was also discovered at the manufacturing firm.

An investigation conducted from May 7 to May 22 of this year found that the manufacturing firm that creates the toothpaste in Sanford, Maine, "failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile," according to a warning letter issued by the FDA on Nov. 5.

Multiple types of bacteria were found at the firm in the last two years, according to the FDA.

USA TODAY has reached out to the manufacturer, Colgate-Palmolive, for comment.

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Bacteria found in toothpaste

Multiple samples of water taken from the firm from June 2021 to October 2022 contained Pseudomonas aeruginosa, the letter stated. The water that was sampled was used to make Tom’s Simply White Clean Mint Paste and to rinse off equipment.

"Water is a major ingredient in many of your OTC drug products," the FDA stated in its letter. "It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.

The bacteria is commonly found in soil and water, but it can cause infections among humans, according to the Centers for Disease Control and Prevention, CDC.

The bacteria can cause infection in the following:

• Blood
• Lungs (i.e. pneumonia)
• Urinary tract

The bacteria can also cause infections in other parts of the body, but these are the areas listed by the CDC.

Paracoccus yeei was found in finished products of Tom's of Maine's Wicked Cool! Anticavity Toothpaste, batch 3025UST11B, stated the FDA.

The toothpaste is marketed towards children "transitioning to adult toothpaste," according to Tom's of Maine's website.

The bacteria found in the product have been linked to conjunctivitis and peritonitis, according to CBS News.

Conjunctivitis is commonly known as "pink eye." Peritonitis is "a serious condition that starts in the abdomen," according to the Mayo Clinic. It occurs when the peritoneum, a thin layer of tissue in the abdomen, becomes inflamed. This is usually due to an infection from bacteria or fungi.

'Black mold-like substance' found in buildings

The FDA's investigator found "black mold-like substance" in the firm at the base of a hose and behind a water storage tank.

The substance was a foot away from tools and objects used to produce the toothpaste.

Investigators also found "powder residue" on trays next to a batch of Tom’s Silly Strawberry Anticavity toothpaste, which is also marketed towards children.

The investigator spotted the residue on the trays before "the addition of any solid raw materials," according to the letter.

"It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination," it stated.

No recalls

No recalls have been issued at this time for any of the Tom's of Maine toothpastes related to the FDA's investigation.

However, the FDA advised the company to provide a "detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry."

It also states that the company is required to submit the results of test reserve samples of toothpastes and indicate the actions it will take pending the test results.

The FDA asked the company to specify what actions it would take in response to its risk assessment, which could also include customer notifications or product recalls.

Company to fix the issues

Colgate-Palmolive is working with the FDA to address the issues raised during the inspection, a spokesperson told ABC News in a statement.

"We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make," according to the company.

"In addition, we have engaged water specialists to evaluate our systems at Sandord, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues."

This story has been updated to clarify one of the bacteria found in the toothpaste.

Julia is a trending reporter for USA TODAY. You can connect with her on LinkedIn, follow her on X, formerly known as Twitter, Instagram and TikTok: @juliamariegz, or email her at [email protected]