The FDA said Hydrox Labs of Elgin, Ill., the manufacturer of the product, and Cardinal Health Inc. (NYSE:CAH) of Dublin, Ohio, initiated the recall when the mouthwash tested positive for the Burkholderia cepacia bacterium. Although it poses little risk to healthy people, the FDA said people with weakened immune systems or chronic lung diseases might be more susceptible to B. cepacia infections.

The mouthwash was distributed to hospitals, medical centers and long term care facilities nationwide.

Being recalled are four-ounce bottles with the lot code 26228 stamped on the Cardinal Health label on the bottle's side.

The mouthwash can also be found in certain Personal Hygiene Hospital Admission Kits. Consumers receiving the mouthwash from a healthcare provider are urged to check the lot number and to contact the company for instructions at 800-292-9332.