The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0888-2023·Announced 2023-07-05

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

Part of a larger recall action

This product is one of 11 recalled by Homeocare Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Homeocare Laboratories, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls