Class I Recall for Contaminated Mouth Spray

Microbial contamination has prompted HomeoCare Laboratories Inc. to recall 31 811 bottles of StellaLife VEGA Oral Care spray, according to the July 24, 2024, US Food and Drug Administration (FDA) Enforcement Report. The FDA designated the recall Class I, which warns use of the affected products could cause serious adverse health consequences or death.

Multiple Bacillus species organisms were identified in the recalled spray, the FDA reported.

“In the immunocompromised population, there is a risk that use of the product could result in severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis,” HomeoCare Laboratories stated in a June 5, 2024, announcement.

The Class I recall affects unflavored StellaLife VEGA Oral Care spray in 1-fluid-ounce spray bottles (NDC 69685-121-01) from lot 2552 (Exp. 2/28/26). 

Additionally, HomeoCare Laboratories is recalling 31 110 bottles of StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse for the presence of Terribacillus. The recall, designated Class II by the FDA, affects StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse in 16-fluid-ounce bottles (NDC 69685-143-16) from lot 2550 (Exp. 2/28/26). 

Both products were distributed by StellaLife, Aventura, Florida, to dental offices throughout the United States.

HomeoCare Laboratories voluntarily initiated the recalls on June 5, 2024. On July 17, 2024, the FDA issued the Class I and II designations. A Class II designation communicates use of the affected product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

In its June 5, 2024, statement, HomeoCare Laboratories said it had received no reports of adverse events related to either of the recalled products.

The homeopathic oral care spray and rinse are marketed to promote oral health, hydrate oral cavities, and support healthy gums.