The Recall Desk
ModerateFDA (Drugs)·D-0889-2023·Announced 2023-07-05

Oral care gel recalled nationwide for manufacturing quality deviations

StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.

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 Class II FDA recall for manufacturing process deviations (cGMP violations). No illnesses, injuries, or hospitalizations have been reported in the source. The recall is voluntary and precautionary in nature, reflecting a compliance issue rather than documented product harm.

Plain-English summary

StellaLife VEGA Oral Care Gel, sold in 1 fluid ounce (30 ml) tubes, is being recalled. Manufactured by Homeocare Laboratories, Inc. and distributed by StellaLife, Inc., the product was distributed nationwide throughout the United States, with approximately 38,105 tubes affected.

The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) standards. These deviations indicate that manufacturing conditions did not meet regulatory quality control requirements.

The recall affects specific lot numbers: #2334 (September 2023 expiration), #2363 (November 2023 expiration), and #2365 (January 2024 expiration). Consumers who have purchased product with these lot numbers should stop using it and contact StellaLife, Inc. for instructions on return or disposal.

This recall was voluntarily initiated by the manufacturer on June 5, 2023. The FDA classified it as a Class II recall, and the recall status was terminated on September 16, 2024.

The recalled product

Product
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
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 #2334
  • exp. date Sep-23
  • 2363
  • exp. date Nov-23
  • 2365
  • exp. date Jan-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.

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Same hazard · cgmp violation

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