CLASS I Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report
Stellalife Vega Oral Care, Spray, Unflavored recalled
Homeocare Laboratories is recalling Stellalife Vega Oral Care, Spray, Unflavored, distributed nationwide in the US. The recall was initiated on 5 Jun 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0609-2024
- FDA event ID
- 94782
- Recalling firm
- Homeocare Laboratories, Yonkers, NY
- Manufacturer
- StellaLife, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jun 2024
- FDA classified
- 17 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 5 Jun 2024 | Recall initiated by company | |
| 17 Jul 2024 | Classified by FDA | +42 days |
| 24 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Where it was distributed
Nationwide to 60 Physician offices
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Which lots are affected?
Lot # 2552, exp. date 02-28-2026
Where was it sold?
Nationwide to 60 Physician offices
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 1 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94782This product is part of a recall event; the main page for the event is Stellalife Advanced Formula Peppermint, Vega Oral Care, Rinse recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stellalife Advanced Formula Peppermint, Vega Oral Care, Rinse recalledStellalife Vega Oral Care Peppermint | Homeocare Laboratories | Sterility | Nationwide |
More recalls from Homeocare Laboratories
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Stellalife Advanced Formula Peppermint, Vega Oral Care, Rinse recalledStellalife Vega Oral Care Peppermint | Homeocare Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Kanjo Homeopathic Pain Relief Cream With Arnica recalled | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | StellaLife VEGA Oral Care Gel tubes recalled by Homeocare Laboratories | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | DoloEar Earache Drops recalled by Homeocare Laboratories | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | StellaLife VEGA Oral Care Rinse, Peppermint recalledStellalife Vega Oral Care Rinse | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |