Blaine Labs Recalls Revitaderm and Tridergel Wound Care Gel Due to Microbial Contamination
Summary
Blaine Labs, Inc. has voluntarily recalled three lot numbers of Revitaderm and Tridergel Wound Care Gel products (BL3608, BL3435, BL3525) distributed nationwide to healthcare providers due to contamination with Lysinibacillus fusiformis, an environmental spore-forming bacterium. The contaminated 1 oz. and 3 oz. antiseptic wound gels pose infection risk to patients with open wounds, compromised skin barriers, or weakened immune systems.
What changed
Blaine Labs initiated a voluntary nationwide recall of three lot numbers of Revitaderm and Tridergel Wound Care Antiseptic Gel products after testing revealed contamination with Lysinibacillus fusiformis, an environmental organism. The affected products include 1 oz. bottles and 3 oz. tubes distributed to healthcare providers (doctor's offices) nationwide. No adverse events have been reported to date.
Healthcare providers should immediately review their inventory for the recalled lots and cease all use and distribution. Patients with open wounds, compromised skin barriers, or weakened immune systems (elderly, diabetic, or immunocompromised) face increased risk of infection, skin irritation, or delayed wound healing. In severe cases, immunocompromised individuals may develop life-threatening complications such as endocarditis or central nervous system infection.
What to do next
- Immediately discontinue use and distribution of affected lot numbers BL3608, BL3435, and BL3525
- Quarantine and segregate all recalled product inventory
- Notify patients who received the recalled wound care gel and advise them to stop using the product
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Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Summary
Company Announcement Date:
April 08, 2026
FDA Publish Date:
April 08, 2026
Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain Lysinibacillus fusiformis, an environmental organism Company Name: Blaine Labs, Inc. Brand Name: Brand Name(s) Revitaderm, Tridergel Product Description: Product Description Antiseptic wound care gel bottles and tubes
Company Announcement
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: Contact@blainelabs.com
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.
Company Contact Information
Consumers: Blaine Labs, Inc (800) 307-8818 Contact@blainelabs.com
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Content current as of:
04/08/2026
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