Homeopathic StellaLife Oral Care Products Recalled

HomeoCare Laboratories Inc. is recalling two batches of Homeopathic StellaLife Oral Care Products citing microbial contamination, according to the U.S. Food and Drug Administration.

The recall involves Homeopathic Stella Life Vega Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse manufactured in 2024, which are marketed to promote oral health, hydrate oral cavities and support healthy gums. The recall is to be performed at the consumer level.

StellaLife VEGA Oral Care, Spray Unflavored comes with NDC 69685-121-01, lot no. 2552 and expiration date of 02-2026.

StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse comes with NDC 69685-143-16, lot no. 2550, and expiration date of 02- 2026.

The affected products were manufactured at HomeoCare Laboratories, shipped nationwide, and distributed through various dental practices.

As per the FDA, higher than acceptable levels of TAMC was found in the Advanced Formula Peppermint Vega Oral Care Rinse, while Bacillus sp was found in the StellaLife Vega Oral Spray, Unflavored.

Bacillus is a common species found in the environment and are generally non-pathogenic, while patients with oral disease, undergoing dental surgical procedures or with compromised immune systems hold potential risks.

In the immunocompromised population, the impacted product may cause severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis.

However, the manufacturer of homeopathic products has not received any reports of adverse events related to these two recalled products so far.

Dental practices and consumers, who have the recalled products, are urged to return the impacted products to HomeoCare Laboratories or to the place of purchase or discard them.

The company said it is implementing enhanced quality control measures to prevent recurrence.

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