Revitaderm, Tridergel (Antiseptic wound care gel bottles and tubes/Blaine Labs, Inc.) Recall reason: Products were found to contain Lysinibacillus fusiformis, an environmental[...]

COMPANY ANNOUNCEMENT

Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination

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Summary

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: [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.

• Content current as of:

  04/08/2026

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