TOPIC: Homeopathic StellaLife Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse by HomeoCare Laboratories: Recall - Due to Microbial Contamination

AUDIENCE: Consumer, Patient, Health Professional, Dentistry

ISSUE: HomeoCare Laboratories is recalling two batches of Homeopathic StellaLife Oral Care Products manufactured in 2024 due to FDA findings of microbial contamination. 

Risk Statement: The two (2) products were found to contain higher than acceptable levels of TAMC (found in the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse) and Bacillus spp. (found in the StellaLife Vega Oral Spray, Unflavored).

While Bacillus is a common species found in the environment and are generally non-pathogenic, we understand the concerns regarding potential risks, especially among patients with oral disease, undergoing dental surgical procedures or with compromised immune systems.

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.  It is important to note that no adverse events related to these two (2) products have been reported to HomeoCare to date.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: These Homeopathic products are marketed to promote oral health, hydrate oral cavities, and support healthy gums.

RECOMMENDATIONS:

• Consumers that have products which are being recalled should stop using the products and return them to place of purchase or discard them.  Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
• Dental practices who have the recalled products should examine their inventory and cease dispensing and return any of the impacted lots to HomeoCare Laboratories.
• Consumers with questions regarding this recall can contact:
• HomeoCare Inc. by phone at (914) 920-5991 or by e-mail at: qualityassurance@homeocare.com.
• StellaLife by phone at (305) 788-8555 or by e-mail at: support@stellalife.com.

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.