FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations
The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall represents a risk-of-harm product due to manufacturing practice deviations. No illnesses or injuries have been reported, which precludes a higher severity classification but warrants High due to the potential hazard from cGMP violations.
Plain-English summary
StellaLife VEGA Oral Care Spray, manufactured by Homeocare Laboratories, Inc., is being recalled by the FDA due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide in 1 fl oz (30 ml) bottles with NDC 69685-101-02.
The recall affects approximately 40,034 tubes across three lots: Lot 2335 (September 2023 expiration), Lot 2364 (November 2023 expiration), and Lot 2408 (February 2024 expiration). The manufacturer voluntarily initiated the recall on June 5, 2023.
Consumers in possession of the recalled product should discontinue use and contact the manufacturer or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Oral Care
- Hazard
- manufacturing-defect
- cgmp-deviation
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 (6)
- Lot # 2335
- exp. date Sep-23
- 2364
- exp. date Nov-23
- 2408
- exp. date Feb-24
Distribution
Distributed nationwide across the United States.
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