Class I U.S. Food and Drug Administration

Revitaderm, Tridergel Antiseptic wound care gel bottles and tubes recall: Products were found to contain Lysinibacillus fusiformis

Recall published 7 months ago

Products were found to contain Lysinibacillus fusiformis, an environmental organism

Revitaderm, Tridergel Prescription & OTC drugs — recalled prescription & otc drugsRevitaderm, Tridergel 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

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing.

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

Recall number
D-0692-2026, D-0693-2026, D-0699-2026
Published
April 8, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Revitaderm, Tridergel
Product type
Prescription & OTC drugs
Units affected
1,171 - 1 oz bottles; 519 - 1 oz bottles; 5,555 bottles and tubes
Distribution
Nationwide
Lot / code info
Lot#: BL3608, Exp. 07/01/28. — Lot #: BL3435, Exp. 11/06/26 — Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27

Products covered by this recall

Antiseptic wound care gel bottles and tubes

What the company announced

Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.

The affected product has been found to contain Lysinibacillus fusiformis , an environmental organism.

Risk Statement

This voluntary recall has been initiated as a precautionary measure due to the detection of microbial presence. The tested samples identified the presence of Lysinibacillus fusiformis . Lysinibacillus fusiformis is an environmental, spore-forming bacterium.

While it is generally considered to have low pathogenicity in healthy individuals, it can survive in adverse conditions and may act as an opportunistic organism. Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing. In immunocompromised individuals, including those with poorly controlled diabetes, elderly individuals with immune senescence, and young children with an immature immune system, these infections may become severe and lead to life-threatening complications such as endocarditis or central system infection.

The product is used as a topical antiseptic for first aid to help prevent the risk of infection in minor cuts, scrapes, and burns and is packaged in a 1 oz. bottle and 3 oz. tube. The Revitaderm® Wound Care Gel can be identified by its purple trim and Tridergel™ Wound Care can be identified by its light blue trim. The 1 oz. bottle has two cap configurations, twist and longer pointy cap, and is secured with a shrink / body band. The bottle has the expiration date and lot number printed on the bottom portion of the bottle. The 3 oz. is a tube and contains the lot number and expiration date imprinted along the crimp at the top of the tube. Revitaderm® Wound Care Antiseptic Gel 1 oz. & 3 oz. and Tridergel™ Wound Care 1 oz. was distributed nationwide in the U.S to healthcare providers (doctor’s offices) they were not distributed for retail or internet sales.

Product Description: 1 oz. & 3 oz. Revitaderm® Wound Care Antiseptic Gel

Active Ingredient: Benzalkonium Chloride 0.1%

Lot Number/EXP Date/Packaging: BL3608, 07/01/28 Printed with Yellow ink on the bottom of the bottle (1 oz.), shorter twist cap.

Lot Number/EXP Date/Packaging: BL3435, 11/06/26 Printed with Black ink on the bottom of the bottle (1 oz.), long pointy cap

Lot Number/EXP Date/Packaging: BL3435, 11/06/26 Imprinted on the tube crimp (3 oz.)

Lot Number/EXP Date/Packaging: BL3525, 08/07/27 Printed with Black ink on the bottom of the bottle (1 oz.), long pointy cap

Lot Number/EXP Date/Packaging: BL3525, 08/07/27 Imprinted on the tube crimp (3 oz.)

Product Description: 1 oz. Tridergel™ Wound Care

Active Ingredient: Benzalkonium Chloride 0.1%

Lot Number/EXP Date/Packaging: BL3435, 11/06/26 Printed with Black ink on the bottom of the bottle (1 oz.), long pointy cap

To date, Blaine Labs has not received any reports of adverse events related to this recall.

What Customers Should Do

Customers & Healthcare providers should review their inventory for these affected lot number and discontinue use and / or distribution immediately. Immediately stop using the product. Segregate any remaining inventory of these lot numbers and please contact Blaine Labs, Inc to arrange for return.

Blaine Labs, Inc. is notifying its physician clinics by regular mail and by phone, as applicable, and is arranging for the return of undispensed 1 oz. and 3 oz. from lot numbers associated with this recall.

Consumers with questions regarding this recall can contact Blaine Labs, Inc directly by using the contact information listed below Monday through Friday 7:30AM to 4:00PM PST.

Contact Information:

You may also report adverse events or questions regarding this recall directly to Blaine Labs using the contact information below.

Blaine Labs, Inc.

Phone: (800) 307-8818

Address: 11037 Lockport Pl, Santa Fe Springs, California, 90670

Email: [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: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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 25 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.

  • BL3608
  • 01
  • 28
  • BL3435
  • 06
  • 11
  • 26

Best-by / use-by date

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

  • 07
  • 01
  • 28
  • 11
  • 06
  • 26
  • 08
  • 27

NDC number

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

  • 63347-120-02
  • 73352-520-01
  • 63347-120-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 oz
  • 3 oz
  • 1.0 FL OZ
  • 37 mL
  • 29.6 mL
  • 16 mL
  • 3.0 Fl OZ

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

Revitaderm, Tridergel — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Clean and sanitise the fridge shelf, container or surface it was stored on.
  3. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  4. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Blaine Labs, Inc. — Consumers: Blaine Labs, Inc, (800) 307-8818, [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 Revitaderm, Tridergel prescription & otc drugs recalled?

Products were found to contain Lysinibacillus fusiformis, an environmental organism Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code BL3608, 01, 28; best-by date 07 or 01. 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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