Mouthwash is an integral part of any oral hygiene routine—many of us don't feel like our mornings are complete without a quick swish. But you'll want to check your medicine cabinet to make sure you're not using anything that could do more harm than good. The U.S. Food and Drug Administration (FDA) announced that HomeoCare Laboratories Inc. has recalled StellaLife mouthwash, as well as an oral spray, due to potential microbial contamination.
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According to a June 4 press release from the FDA, HomeoCare Laboratories is voluntarily recalling two batches of its Homeopathic StellaLife Oral Care Products, specifically the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse and the StellaLife Vega Oral Spray, Unflavored. The products are advertised to support oral health, hydrate oral cavities, and support healthy gums.
The recall was initiated after the FDA found "higher than acceptable levels" of total aerobic microbial count (TAMC) in the oral care rinse and higher levels of Bacillus species in the oral spray.
"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," the FDA release reads.
For those who are immunocompromised, use of these oral care products 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," the release adds.
However, HomeoCare hasn't received any reports of adverse events related to the products as of June 5.
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"We take these findings seriously and are taking immediate action to address the situation. We have initiated a voluntary recall of the two (2) affected batches listed below and are implementing enhanced quality control measures to prevent recurrence," a HomeoCare statement in the FDA press release reads. "Our priority remains the safety and well-being of our consumers, and we are committed to transparency and accountability throughout this process."
Both products were shipped nationwide to customers and to dental practices. You can identify the recalled products by the lot number and expiration date printed in black on the bottom left hand corner of the front label. The oral care rinse has a lot number of 2550 and an expiration date of Feb. 2026. Recalled oral care spray has lot number 2552, and also has an expiration date of Feb. 2026.
If you have either of these products at home, the FDA asks that you stop using them and either return them to your place of purchase them or throw them away. Dental practices are advised to check their inventory for these products and to stop dispensing them.
Consumers who experience issues that may be related to the recall should reach out to their doctor or healthcare provider for guidance. If you have questions about the recall itself, you can contact HomeoCare Inc. or StellaLife using the contact information provided in the FDA release.
The FDA also asks that you report any quality problems or adverse events to its MedWatch Adverse Event Reporting program. You can do so by completing and submitting a report online or via regular mail or fax.
