Table of contents
- Latest B. Cepacia Lawsuit Updates
- August 28, 2025: FDA Posts Expanded DermaRite Recall
- August 8, 2025: DermaRite Announces Nationwide Recall
- July 16, 2025: DermaRite Starts Voluntary Recall
- August 18, 2021: FDA Warns Providers About Eco-Med Ultrasound Gels
- August 4, 2021: Eco-Med Recalls Eco-Gel 200 Lots
- December 23, 2019: Mavidon Announces Worldwide Recall
- May 8, 2018: Medline Foam Outbreak Announced
- August 11, 2017: FDA Warns About PharmaTech Products
- January 11, 2017: CDC Counts Saline Flush Cases
- October 4, 2016: Nurse Assist Recalls Saline Syringes
- August 10, 2016: FDA Updates PharmaTech Recall
- What Is B. Cepacia?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- Can You Get Rid of B. Cepacia?
- What Diseases Does B. Cepacia Cause?
- Did DermaRite Report Adverse Events from the 2025 Recall?
- What Does the Research Say About B. Cepacia Outbreaks?
- How Can I Contact DermaRite About the Recall?
B. cepacia contamination has been tied to recalls of soaps, creams, gels, saline syringes and liquid medicines, and to infections in patients who used them, especially people with weakened immune systems or chronic lung disease.
In 2025, DermaRite Industries recalled lots of personal care products over Burkholderia cepacia complex. Two individual lawsuits over DermaRite products are reported as pending. Earlier suits named PharmaTech LLC. No MDL has been formed.
Other affected products include Eco-Med ultrasound gels, Mavidon skin-prep products and Nurse Assist syringes. If you still have a recalled product, stop using it and check its lot number against the FDA recall notice.
Latest B. Cepacia Lawsuit Updates
August 28, 2025: FDA Posts Expanded DermaRite Recall
FDA posted the expanded nationwide recall from DermaRite Industries on August 28, 2025. The company had announced it on August 27 [1].
The expansion added products and lots, such as hand sanitizers, cleansers, skin protectants and deodorant, over potential Burkholderia cepacia complex contamination. FDA posts company recall announcements as a public service and does not endorse the product or the company.
August 8, 2025: DermaRite Announces Nationwide Recall
DermaRite Industries announced a voluntary nationwide recall on August 8, 2025. It covers lots of DermaKleen, DermaSarra, KleenFoam and PeriGiene because of Burkholderia cepacia contamination [2]. FDA posted the notice on August 9, 2025.
July 16, 2025: DermaRite Starts Voluntary Recall
The FDA expansion notice reports that DermaRite Industries started its voluntary recall on July 16, 2025. The recall concerns potential Burkholderia cepacia complex contamination in DermaRite products.
August 18, 2021: FDA Warns Providers About Eco-Med Ultrasound Gels
FDA asked healthcare providers on August 18, 2021 to stop using and discard all ultrasound gels and lotions made by Eco-Med Pharmaceutical. The reason was a risk of Burkholderia cepacia complex contamination [3].
CDC reports the request went beyond the company’s own earlier recall, which covered only some lots.
August 4, 2021: Eco-Med Recalls Eco-Gel 200 Lots
Eco-Med Pharmaceutical issued a voluntary recall on August 4, 2021. CDC reports it was limited to several lots of Eco-Gel 200 ultrasound gel.
FDA’s request two weeks later reached all of the company’s ultrasound gels and lotions. CDC links the gel to possible contamination with this bacteria.
December 23, 2019: Mavidon Announces Worldwide Recall
Mavidon announced a voluntary worldwide recall on December 23, 2019, over Burkholderia cepacia contamination. FDA posted it on January 8, 2020 [4]. The recall covers LemonPrep, PediaPrep, Wave Prep and Cardio Prep products.
May 8, 2018: Medline Foam Outbreak Announced
FDA listed the company announcement dated May 8, 2018. It concerned a multistate B. cepacia complex outbreak linked to Medline Remedy Essentials No-Rinse Cleansing Foam [5].
The foam was made by Shadow Holdings, doing business as Bocchi Laboratories. FDA lists the recall as completed and terminated.
August 11, 2017: FDA Warns About PharmaTech Products
On August 11, 2017, FDA warned of possible B. cepacia contamination in several brands of drugs and dietary supplements made by PharmaTech LLC. CDC records a recall of its liquid products, regardless of manufacture or expiration date [6].
January 11, 2017: CDC Counts Saline Flush Cases
CDC reported 164 cases from 59 facilities as of January 11, 2017, in a saline flush syringe outbreak [7]. The outbreak was traced to prefilled syringes made by Nurse Assist.
October 4, 2016: Nurse Assist Recalls Saline Syringes
CDC reports that Nurse Assist voluntarily recalled and removed all its prefilled saline flush syringes on October 4, 2016. The recall was the company’s own action and covered every prefilled saline flush syringe it made.
August 10, 2016: FDA Updates PharmaTech Recall
FDA released an updated statement on August 10, 2016 that included a voluntary recall of all liquid products manufactured by PharmaTech. CDC had confirmed 60 cases from 8 states at that point.
What Is B. Cepacia?
According to the CDC, Burkholderia cepacia complex (Bcc) is a group of bacteria commonly found in soil and water [8]. The CDC says Bcc poses little medical risk to healthy people.
Who May Be Affected?
People in healthcare settings are at highest risk of B. cepacia complex infection, the CDC says. So are people with weakened immune systems or chronic lung diseases, particularly cystic fibrosis.
Past outbreaks involved IV flush syringes, oral liquid docusate, ultrasound gel and a no-rinse cleansing foam used on hospital patients. The DermaRite notices warn that infection can spread to the bloodstream in immunocompromised people.
You may match these circumstances if you used a recalled DermaRite product. You may also match them if you were treated with Eco-Med gel, Nurse Assist syringes or another recalled product.
Whether you qualify depends on an individual legal review with a lawyer, who can look at your records, your diagnosis and the product you used.
Reported Injuries or Damages
Two lawsuits over DermaRite products allege a failure to disclose possible Burkholderia cepacia complex contamination. The suits say this raises the risk of serious infections and sepsis.
Fenton was filed in the U.S. District Court for the Western District of Pennsylvania in September 2025. Wright was filed in the Eastern District of New York in October 2025. Both are reported as pending.
Fierce Pharma reported seven lawsuits against PharmaTech LLC on behalf of infected patients [9]. They include three infants who died after taking a stool softener. These are allegations.
FDA’s DermaRite notice says use in healthy people with minor skin lesions may cause local infections. In immunocompromised people, the infection could spread into the blood stream and lead to life-threatening sepsis.
The CDC outbreak page lists 7 deaths among the saline flush cases. It says it has not been determined whether the infection, underlying health conditions or another cause led to the deaths.
The 2022 Epidemiology and Infection study by CDC, FDA and state health authors found 60 infections in six states. They were linked to a no-rinse cleansing foam. FDA inspection found poor manufacturing practices [10].
Recall and Regulatory Background
Recalls tied to B. cepacia come from several makers. Each notice covers different products, lots and dates, so check the notice for the product you used.
PharmaTech liquid docusate was sold as Rugby Diocto and other brands. A recall does not prove liability or show that a product caused any one infection.
Evidence to Preserve
Keep these items if you used a product named in a B. cepacia recall or outbreak:
- The product name, lot number and expiration date from the package
- The product itself, sealed and unused if you can
- Purchase records, facility supply records and receipts
- Photos of the product and of any visible injury
- Medical records, culture results and lab results showing a B. cepacia infection
- Hospital, clinic and pharmacy records
- Messages with the maker, the seller or the facility
Filing Deadlines
State law sets the time limits for filing an injury claim, and the limit that applies depends on where you live. It also depends on when the exposure, illness or injury and the diagnosis happened.
Missing a filing date can end a claim, however strong the facts are. A lawyer can tell you which limit applies to you, so ask soon.
Potential Compensation
Depending on the case, damages may include medical expenses, lost income and pain and suffering. In wrongful death cases they may include funeral costs and loss of companionship.
No settlement or verdict has been reported in a B. cepacia contamination case. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation depends on the facts of each claim.
Frequently Asked Questions
Can You Get Rid of B. Cepacia?
Getting rid of B. cepacia is difficult. The CDC says treatment decisions are made case by case but generally include antibiotics. Many B. cepacia complex germs resist antibiotics, which makes them hard to treat.
What Diseases Does B. Cepacia Cause?
B. cepacia causes illness that ranges from no symptoms to serious lung infections, the CDC says. Fever and fatigue may also occur. In the foam outbreak, the most common infection site was the urinary tract.
Did DermaRite Report Adverse Events from the 2025 Recall?
DermaRite said, when it announced the first recall, that it had not received any reports of adverse events related to the recall. That statement comes from DermaRite, not from a regulator.
What Does the Research Say About B. Cepacia Outbreaks?
Research on B. cepacia outbreaks includes CDC’s ultrasound gel report. As of August 18, 2021, CDC knew of at least 59 patients in 6 states, 48 with bloodstream infections. The strain matched four lots of MediChoice M500812 gel.
How Can I Contact DermaRite About the Recall?
You can contact DermaRite about the 2025 recall through Sedgwick, the contact named in the expansion notice. The number is 888-943-5190 and the email is dermarite5186@sedgwick.com. The details were current as of August 28, 2025.