DermaRite Industries has voluntarily recalled multiple lots of four over-the-counter products after testing detected a dangerous bacteria. The affected products include DermaKleen antiseptic lotion soap, KleenFoam antimicrobial foam soap, PeriGiene antiseptic cleanser, and DermaSarra external analgesic.
The recall, announced on August 8, 2025, comes after the company discovered Burkholderia cepacia complex (Bcc) contamination in these products. The FDA published the recall notice on August 9.
Bcc is a group of bacteria found in soil and water that can spread through contaminated products or from person to person. While it poses little risk to healthy people, it can cause serious infections in those with weakened immune systems.
“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,” the FDA stated in the recall notice.
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People with cystic fibrosis or chronic lung disease face particularly high risk. The CDC notes that Bcc can be resistant to antibiotics, making infections difficult to treat. Symptoms may include fever, fatigue, and respiratory problems.
The recalled products were distributed nationwide across the United States and Puerto Rico. The company said no adverse events had been reported as of the announcement date.
Consumers can identify affected products by checking specific lot numbers and expiration dates. DermaKleen products (reorder numbers #0090BB and #0092BB) have expiration dates between July 2025 and February 2027. KleenFoam (reorder #0093F) expires between August 2025 and January 2027. DermaSarra (reorder #00188) expires February 2026, and PeriGiene (reorder #00198) expires between November 2025 and January 2027.
DermaRite has notified its distributors and customers to immediately examine their inventory and destroy affected products according to facility protocols. Consumers should stop using these products immediately and contact their healthcare provider if they experience any problems.
Those with questions about the recall can contact DermaRite at 973-569-9000 ext. 104 (Monday through Friday, 9 a.m. to 5 p.m. ET) or email [email protected]. The FDA encourages consumers to report adverse effects to its MedWatch Adverse Event Reporting program.