Antiseptic wound care gel bottles and tubes

  • Products were found to contain Lysinibacillus fusiformis, an environmental organism
  • Company: Blaine Labs, Inc.
  • Drugs
  • FDA
  • April 8, 2026

Product details

  • Antiseptic wound care gel bottles and tubes

Company announcement

Blaine Labs, Inc. is recalling wound care gel products nationwide due to contamination with Lysinibacillus fusiformis.

The products, Revitaderm and Tridergel Wound Care Gel, were distributed to healthcare providers and not for retail sale.

No adverse events have been reported to date.

Risk:

Patients with open wounds, compromised skin barriers, or weakened immune systems 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.

Impacted states: Nationwide

Products:

- Revitaderm® Wound Care Antiseptic Gel 1 oz.

- Revitaderm® Wound Care Antiseptic Gel 1 oz.

- Revitaderm® Wound Care Antiseptic Gel 3 oz.

- Revitaderm® Wound Care Antiseptic Gel 1 oz.

- Revitaderm® Wound Care Antiseptic Gel 3 oz.

- Tridergel™ Wound Care 1 oz.

Contact

For more information, call (800) 307-8818 or email Contact@blainelabs.com.

View the original FDA notice

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