Manufacturer expands recall of antiseptic cleansers to include dozens of deodorants, shampoos over Burkholderia cepacia contamination

DermaRite Industries expanded an urgent recall of antiseptic soaps it markets for use by immunocompromised patients after testing found contamination with the bacteria Burkholderia cepacia, the New Jersey-based manufacturer said. The expansion adds dozens of deodorants, shampoos, lotions and hand sanitizers to an earlier July recall of several cleansers.

The company said the affected products were distributed across the United States and Puerto Rico and include items sold under brand names such as DermaKleen, DermaSarra, KleenFoam and PeriGiene, along with 28 additional brand names. DermaRite said consumers and healthcare facilities that received shipments should examine inventory and destroy all affected products and that people who used the products and have health concerns should contact their physician.

DermaRite said in a news release that exposure to B. cepacia could “result in serious and life-threatening infections” and sepsis, an extreme immune response that can damage organs and tissues. The company said it has not received any reports of infections linked to the recalled products to date, and it did not disclose how the contamination occurred.

Burkholderia cepacia is known to cause persistent and difficult-to-treat infections in people with weakened immune systems, particularly those with cystic fibrosis, clinicians and public health officials say. The bacterium can colonize the lungs for life in infected patients and resists many common antibiotics. Some antibiotics such as trimethoprim-sulfamethoxazole (Bactrim), meropenem and ceftazidime have shown effectiveness in some cases, but there is no single established universal treatment. Physicians often use combinations of oral and intravenous antibiotics when treating infections.

People with cystic fibrosis, who number about 40,000 in the United States, are especially vulnerable; roughly 1,000 new cases of cystic fibrosis are diagnosed each year, most commonly in children under age two. Studies and clinical reports indicate that about one in five people with cystic fibrosis who carry B. cepacia progress to severe illness. In some instances the bacterium can cause a rapidly progressing pneumonia known as Cepacia syndrome, which can destroy lung tissue and has been associated with mortality rates approaching 75 percent in severe cases. Other immunocompromised groups at elevated risk include people receiving cancer treatment, those with sickle cell disease and patients with serious burns.

B. cepacia can spread from person to person through respiratory droplets produced by coughing or sneezing. It also can contaminate medical equipment and thrive in moist environments such as sinks, humidifiers and other damp areas in homes or health care settings, public health experts say.

DermaRite’s expanded recall lists numerous affected lots and expiration dates, many with expiry dates through August 2027. The recalled items encompass a wide range of product types and packaging formats, including bag-and-box dispensers, pumps, jars, tubes and single-use packets. The company’s public notice urges retailers and health care providers to quarantine and dispose of the products rather than returning them to the manufacturer. It also asks consumers who experience adverse events to contact their health care provider.

Federal and state health authorities typically work with manufacturers to notify purchasers and to monitor for reports of illness following recalls involving potential microbial contamination. DermaRite did not identify a specific supplier or production step as the source of contamination in its release.

Laboratory identification of B. cepacia in nonsterile topical products has prompted past recalls because of the organism’s capacity to cause invasive disease in vulnerable patients. When such organisms are identified, regulators and infection-prevention experts emphasize removing contaminated lots from circulation, notifying potentially exposed facilities and advising clinicians to consider the organism in patients with compatible symptoms and relevant exposure histories.

Consumers seeking to determine whether a particular item is affected should consult the recall notice issued by DermaRite or contact the company directly. Health care facilities that used affected products on or near immunocompromised patients may need to notify clinicians and patients in accordance with facility policies and public health guidance.

DermaRite’s recall notice includes a detailed list of product descriptions, item numbers and lot or expiration information for the affected items. The company reiterated that while healthy individuals with minor skin lesions might experience localized infections from contact with contaminated products, immunocompromised individuals face a higher risk that infection could spread into the bloodstream and lead to life-threatening sepsis.