StellaLife Oral Care Rinse Recalled Due to Infection Risk

A recent announcement by the Food and Drug Administration (FDA) has prompted the voluntary recall of two specific batches of StellaLife homeopathic oral care products. The recall, initiated by the manufacturer, HomeoCare Laboratories Inc., targets the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse and the StellaLife Vega Oral Spray, Unflavored.

The impetus for the recall stems from findings of microbial contamination identified during routine FDA testing. The testing revealed elevated Total Aerobic Microbial Count (TAMC) levels within the peppermint-flavored rinse and Bacillus sp. bacteria in the unflavored spray. While Bacillus sp. is commonly found in the environment and typically harmless, the FDA acknowledges concerns regarding potential risks, particularly for vulnerable populations.

Individuals with compromised immune systems, those undergoing dental surgery, or patients already experiencing oral health issues may be susceptible to more severe complications. In these cases, the introduction of bacteria through the use of contaminated oral rinse could potentially lead to bacteremia, a condition characterized by the presence of bacteria in the bloodstream, and even sepsis, a life-threatening response to infection.

It is important to note that, to date, HomeoCare Laboratories has not received reports of any adverse events associated with the recalled products. Nevertheless, in an abundance of caution and to safeguard consumer health, the company has undertaken a comprehensive recall effort.

The recall encompasses products manufactured in 2024 and can be identified by the following details:

• StellaLife VEGA Oral Care, Spray Unflavored:
  • NDC: 69685-121-01
  • Lot No: 2552
  • Release Date: 03/28/2024
  • Expiration Date: 02-2026
• StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse:
  • Specific lot and expiration details not publicly disclosed

Consumers in possession of the products above are instructed to discontinue use immediately. They are advised to return the recalled items to the point of purchase for a full refund. Alternatively, they can contact HomeoCare Laboratories Inc. for further guidance on proper disposal procedures.

The FDA has issued a public notification regarding the recall, emphasizing the importance of consumer vigilance. They encourage individuals to remain informed about potential product safety concerns and to strictly adhere to the recommendations outlined in official recall notices.