FDA warns – Discovery of microbial contamination leads to recall of Homeopathic StellaLife Oral Care Spray, Unflavored and Advanced Formula Peppermint Oral Care Rinse

Yonkers, New York-based HomeoCare Laboratories Inc. has announced that two batches of its Homeopathic StellaLife Oral Care products were voluntarily recalled at the consumer level because of a microbial contamination, according to the FDA.

Initiated by the company on June 5, 2025, the recall covers two of the following products, which were manufactured in 2024:

  • StellaLife VEGA Oral Care, Spray Unflavored
    • Production date: 02/16/2024
    • Release date: 03/28/2024
    • NDC: 69685-121-01
    • Lot No.: 2552
    • Expiration Date: 02-2026
  • StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse
    • Production Date: 03/01/2024
    • Release Date: 03/28/2024
    • NDC: 69685-143-16
    • Lot No.: 2550
    • Expiration Date: 02-2026

Officials said the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse was found to have levels of TAMC exceeding approved levels, and that the StellaLife Vega Oral Spray, Unflavored, was found to contain Bacillus sp.

Consumers should note that while Bacillus is found throughout the environment, it is, for the most part, a non-pathogenic. Those identified as most at risk are patients facing oral disease or who are otherwise subjected to dental surgical procedures. Individuals with compromised immune systems are especially at risk of suffering major, life-threatening adverse events, in which bacteria is introduced, disrupting the “oral mucosa,” and therefore putting patients at further risk of possibly bacteremia and sepsis.

Despite the possibility of such risks, HomeoCare Laboratories Inc. notes that neither of the products listed above have had any reports of adverse incidents connected with them.

Marketed to promote the oral health, keep oral cavities hydrated and support gum health, the products, which were manufactured at HomeCare Laboratories, were shipped and made available for purchase nationwide at a variety of dental practices.

The company says that following the discovery of the organism in both now-recalled batches, “enhanced quality control measures” were established to mitigate further issues. HomeoCare Laboratories said it continues to value the safety and well-being of its customers as it maintains transparency and accountability at every step of the process.

The company asks dental practices that carry the recalled devices to re-assess their inventory and suspend all sale of the affected products. All affected lots should be arranged for return to HomeoCare Laboratories. Healthcare professionals and consumers alike should cease all use of the products and see that the items are either disposed of or returned to their point of purchase. Any health-related issues experienced while or after using the product should be referred to a physician or healthcare provider.

HomeoCare Inc. may be reached at (914) 920-5991, Monday through Thursday, from 9:00 a.m. to 3:00 p.m. Eastern Time, or via email at qualityassurance@homeocare.com. StellaLife can be contacted at (305) 788-8555 and via email at support@stellalife.com.

The FDA asks that any adverse reactions or quality issues be reported to the agency’s MedWatch program.


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