OTC Oral Care Rinse Recalled for Manufacturing Process Deviations
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary FDA Class II recall with no reported illnesses or injuries, and no specific contamination has been identified. The recall is for manufacturing process control deviations, fitting the rubric criteria for Moderate severity.
Plain-English summary
StellaLife VEGA Oral Care Rinse, a coconut-flavored oral rinse sold in 16 fl oz bottles, was voluntarily recalled by Homeocare Laboratories, Inc. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations, which indicate manufacturing process control issues. The affected product is Lot #2396 with an expiration date of April 2024.
Approximately 16,587 bottles were distributed nationwide across the United States. The recall was initiated on June 5, 2023, and classified by the FDA as Class II on June 26, 2023. The recall was terminated on September 16, 2024.
If you have purchased this product, stop using it and consult with a healthcare provider if you have any health concerns.
The recalled product
- Product
- STELLALIFE VEGA ORAL CARE COCONUT (RISNE)
- Brand
- STELLALIFE VEGA ORAL CARE COCONUT
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Oral Care Rinse
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 2396
- exp. date Apr-24
UPCs (1)
- 0850019861020
Distribution
Distributed nationwide across the United States.
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