STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife...

FDA Drug Recall #D-0609-2024 — Class I — June 5, 2024

Recall Summary

Recall Number D-0609-2024
Classification Class I — Serious risk
Date Initiated June 5, 2024
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Homeocare Laboratories, Inc.
Location Yonkers, NY
Product Type Drugs
Quantity 31,811 x 1 fl. oz. spray bottle

Product Description

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

Reason for Recall

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

Distribution Pattern

Nationwide to 60 Physician offices

Lot / Code Information

Lot # 2552, exp. date 02-28-2026

Other Recalls from Homeocare Laboratories, Inc.

Recall # Classification Product Date
D-0610-2024 Class II STELLALIFE ADVANCED FORMULA Peppermint, VEGA Or... Jun 5, 2024
D-0888-2023 Class II StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml... Jun 5, 2023
D-0882-2023 Class II Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL ... Jun 5, 2023
D-0886-2023 Class II StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ... Jun 5, 2023
D-0884-2023 Class II DoloEar Earache Drops, 0.50 fl. oz. bottles, Di... Jun 5, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.