Elevated risk U.S. Food and Drug Administration

Homeopathic StellaLife Oral Care Products recall: Microbial contamination

Recall published 2+ years ago

Microbial contamination

StellaLife Prescription & OTC drugs — recalled prescription & otc drugsStellaLife Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

What the notice says: In the immunocompromised population, there is a risk that use of the product could result in severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 5, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
StellaLife
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
It is important to note that no adverse events related to these two (2) products have been reported to HomeoCare to date.

Products covered by this recall

Homeopathic StellaLife Oral Care Products

What the company announced

FOR IMMEDIATE RELEASE - Yonkers, NY, 06/05/2024 – HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.

Risk Statement: The following two (2) products listed below were found to contain higher than acceptable levels of TAMC (found in the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse) and Bacillus sp (found in the StellaLife Vega Oral Spray, Unflavored).

While Bacillus is a common species found in the environment and are generally non-pathogenic, we understand the concerns regarding potential risks, especially among patients with oral disease, undergoing dental surgical procedures or with compromised immune systems.

In the immunocompromised population, there is a risk that use of the product could result in severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis.

It is important to note that no adverse events related to these two (2) products have been reported to HomeoCare to date.

We take these findings seriously and are taking immediate action to address the situation. We have initiated a voluntary recall of the two (2) affected batches listed below and are implementing enhanced quality control measures to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency and accountability throughout this process.

These Homeopathic products are marketed to promote oral health, hydrate oral cavities and support healthy gums. The affected products were manufactured at HomeoCare Laboratories, shipped nationwide to our customers, and distributed through various dental practices. The recall includes the following products and lot numbers:

  • Production Date: 02/16/2024 · Release Date: 03/28/2024 · Customers: StellaLife Inc. · Product Name: StellaLife VEGA Oral Care, Spray Unflavored · NDC: 69685-121-01 · Lot No.: 2552 · Expiration Date: 02-2026
  • Production Date: 03/01/2024 · Release Date: 03/28/2024 · Customers: StellaLife Inc. · Product Name: StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse · NDC: 69685-143-16 · Lot No.: 2550 · Expiration Date: 02-2026

Dental practices who have the recalled products should examine their inventory and cease dispensing and return any of the impacted lots to HomeoCare Laboratories.

Consumers that have products which are being recalled should stop using the products and return them to place of purchase or discard them. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Consumers with questions regarding this recall can contact:

HomeoCare Inc. by phone at (914) 920-5991 (09:00am-03:00pm EST Monday through Thursday)

HomeoCare Inc. by email address [email protected]

StellaLife by phone at (305) 788-8555

StellaLife by email at [email protected]

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2552
  • 2550

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 02-2026

NDC number

On the carton and again on the bottle or blister label.

  • 69685-121-01
  • 69685-143-16

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

StellaLife — A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

  1. Stop eating it and keep it separate from other food.
  2. Bag and bin it, or return it to the store for a refund.
  3. Clean and sanitise the fridge shelf, container or surface it was stored on.
  4. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers that have products which are being recalled should stop using the products and return them to place of purchase or discard them.

Company contact: HomeoCare Laboratories Inc. — Consumers: HomeoCare Inc., StellaLife, (914) 920-5991, (305) 788-8555, [email protected], [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was StellaLife prescription & otc drugs recalled?

Microbial contamination In the immunocompromised population, there is a risk that use of the product could result in severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2552, 2550; best-by date 02-2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Consumers that have products which are being recalled should stop using the products and return them to place of purchase or discard them.

Where was the recalled product sold?

It was distributed nationwide.

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