On June 5, 2024, the U.S. Food and Drug Administration (FDA) announced that HomeoCare Laboratories Inc. is voluntarily recalling two batches of StellaLife oral care products to the consumer level because of the presence of microbial contamination.
FDA found that the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse and StellaLife Unflavored Vega Oral Spray contained higher-than-acceptable levels of total aerobic microbial counts and Bacillus sp, respectively.
Although Bacillus is a common species that is generally nonpathogenic, it has the potential for risks, especially among patients who have oral disease, are undergoing dental surgical procedures, or who have compromised immune systems. In immunocompromised individuals, use of the product could result in severe or life-threatening bacteremia and sepsis.
HomeoCare Laboratories said that it has not received any adverse event reports related to the two products to date.
The recall includes the following products:
|
Production Date |
Release Date |
Product Name |
NDC |
Lot Number |
Expiration Date |
|
02/16/2024 |
03/28/2024 |
StellaLife VEGA Oral Care, Spray Unflavored |
69685-121-01 |
2552 |
02/2026 |
|
03/01/2024 |
03/28/2024 |
StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse |
69685-143-16 |
2550 |
02/2026 |
“We take these findings seriously and are taking immediate action to address the situation,” HomeoCare Laboratories said. “We have initiated a voluntary recall of the two affected batches and are implementing enhanced quality control measures to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency and accountability throughout this process.”
Customers who have the recalled products should examine their inventory, cease dispensing, and return any of the affected lots to HomeoCare Laboratories.
Consumers who have the recalled products should stop using them, return them to the place of purchase, or discard them. They should contact their physician or healthcare provider if they experience any problems that may be related to using the products.
Consumers with questions regarding this recall can contact:
- HomeoCare Laboratories by phone at 914-920-5991, from 9 am–3 pm EST, Monday–Thursday, or by email at qualityassurance@homeocare.com
- StellaLife by phone at 305-788-8555 or email at support@stellalife.com
Report any adverse reactions or quality problems experienced with the use of the products to FDA's MedWatch Adverse Event Reporting program.