OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers

  • Contamination with Burkholderia cepacia
  • Company: DermaRite Industries, LL
  • Drugs
  • FDA
  • August 8, 2025

Product details

  • OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers

Company announcement

DermaRite Industries, LLC is voluntarily recalling products due to microbial contamination.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

No adverse events related to this recall have been reported.

Risk:

Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis.

Impacted states: Nationwide

Contact

For more information, call 973-569-9000 x104 or email voluntary.action@dermarite.com.

View the original FDA notice

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