Table of contents
- Latest PeriGiene Recall Updates
- October 27, 2025: FDA Issues Warning Letter to DermaRite
- September 8, 2025: DermaRite Posts Recall Update
- September 2, 2025: Recall Reported as Class I
- August 27, 2025: DermaRite Expands the Recall
- August 8, 2025: DermaRite Announces the Recall
- Which PeriGiene Are Affected?
- Why Was PeriGiene Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Other Recalls, Warnings, or International Actions
- Legal Options
- Frequently Asked Questions
- What Are the Symptoms of Burkholderia Cepacia Infection?
- What Expiration Dates Are on the Recalled PeriGiene Lots?
- What Does the FDA Warning Letter Say About PeriGiene?
- What Was the Original DermaRite Contact for the PeriGiene Recall?
PeriGiene Health Care Antiseptic is part of a voluntary nationwide recall by DermaRite Industries. The cause is contamination with Burkholderia cepacia complex. DermaRite announced the recall on August 8, 2025 and expanded it on August 27, 2025.
The FDA posted both company notices. It sent DermaRite a warning letter on October 27, 2025. The recall status is expanded. Trade press reports a Class I classification.
PeriGiene Health Care Antiseptic is an over-the-counter cleanser for use in the perineal area. DermaRite distributed the recalled lots nationwide in the United States and in Puerto Rico. No lawsuit names PeriGiene.
Latest PeriGiene Recall Updates
October 27, 2025: FDA Issues Warning Letter to DermaRite
The FDA issued warning letter 710997 to DermaRite on October 27, 2025. The letter says the firm’s manufacturing methods do not conform to CGMP, so its drug products are adulterated [1].
The letter also says PeriGiene Health Care Antiseptic is an unapproved new drug. Only the FDA has made these findings.
September 8, 2025: DermaRite Posts Recall Update
On September 8, 2025, DermaRite posted a recall update to customers. It says the company’s wound care and nutritional products are not part of the recall [2]. The letter followed the August 27 expansion to more product lines.
September 2, 2025: Recall Reported as Class I
According to HMP Global’s Pharmacy Learning Network, the FDA finalized a Class I classification for the recall on September 2, 2025 [3].
HMP describes a Class I recall as the most serious type of risk. Use of the product could lead to serious health consequences or death.
August 27, 2025: DermaRite Expands the Recall
On August 27, 2025, DermaRite expanded the recall to more products and lots, including PeriGiene [4]. The expansion covered all lots of all products that contain water, according to the FDA’s October 27 warning letter.
August 8, 2025: DermaRite Announces the Recall
On August 8, 2025, DermaRite announced a voluntary nationwide recall of DermaKleen, DermaSarra, KleenFoam and PeriGiene lots because of Burkholderia cepacia contamination [5]. The recall covers individual lots of these products.
Which PeriGiene Are Affected?
DermaRite’s recall covers these PeriGiene items:
- PeriGiene Health Care Antiseptic, 7.5 oz, 48 per case
- NDC 61924-198-08 (chloroxylenol 0.5%), as listed by HMP Global
- Lots 31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1, 40877.1, 41093A, 50072A and 50079A
Check the bottle or case for the lot number. The FDA says the contaminated products may be used by immunosuppressed people or by people caring for them.
Anyone who used PeriGiene from a listed lot should follow the steps below. Other DermaRite product lines are recalled too, and a later section lists them.
Why Was PeriGiene Recalled?
PeriGiene was recalled because of microbial contamination identified as Burkholderia cepacia complex. The FDA says these bacteria may result in serious and life-threatening infections.
The FDA warning letter says DermaRite began the recall after products failed testing. Some failed for total aerobic microbial count. Retained samples failed for Burkholderia cepacia.
The FDA says healthy people with minor skin lesions are more likely to get local infections. In immunocompromised people, the infection could spread into the blood. That could lead to life-threatening sepsis.
Reported Incidents, Injuries, or Illnesses
In its August 8, 2025 notice, DermaRite said it had received no reports of adverse events related to the recall.
The notices give no recall number and no count of units. The notice says the products went to customers nationwide and in Puerto Rico.
A report alone does not show that PeriGiene caused an illness. If you think PeriGiene harmed you, keep your records and tell your doctor.
What Should Consumers Do?
Follow these steps if you have PeriGiene or used it:
- Stop using PeriGiene and compare its lot number with the lot list above.
- Check any facility inventory and destroy all affected product, as DermaRite told its customers.
- Contact your physician or healthcare provider if you had problems that may be related to using the product. Symptoms may include respiratory problems, fever or fatigue, according to ABC News [6].
- Call the DermaRite recall line run by Sedgwick at 888-943-5190, Monday through Friday, 8:00 am to 5:00 pm EST, or email dermarite5186@sedgwick.com.
- Report adverse reactions or quality problems to MedWatch, the FDA’s reporting program, online at www.fda.gov/medwatch/report.htm or call 1-800-332-1088 for a form [7].
Other Recalls, Warnings, or International Actions
DermaKleen, DermaSarra and KleenFoam were in the August 8, 2025 recall with PeriGiene. The August 27, 2025 expansion added 12 more product lines, including hand sanitizers, skin protectants and an antiperspirant.
The new lines are 4-N-1, DermaCerin, DermaFungal, DermaMed, Gel Rite, Hand E Foam, Lantiseptic, PeriGuard, Renew Dimethicone, Renew Periprotect, Renew Skin Repair and UltraSure.
Legal Options
Two class actions about other DermaRite products are pending, according to Truth in Advertising [8]. A recall does not automatically establish liability or eligibility.
Fenton et al. v. DermaRite Industries LLC, No. 25-cv-282, was filed in September 2025 in the Western District of Pennsylvania.
The second case, No. 25-cv-5977, is styled Wright et al. v. DermaRite Industries, LLC. It was filed in October 2025 in the Eastern District of New York.
Both cases allege failure to disclose that products may contain Burkholderia cepacia complex. These are allegations, not findings. A lawyer can review your own facts.
Frequently Asked Questions
What Are the Symptoms of Burkholderia Cepacia Infection?
Symptoms of Burkholderia cepacia infection may include respiratory problems, fever or fatigue. Many infected people have no symptoms at all. People who are immunocompromised or have chronic lung conditions such as cystic fibrosis are at higher risk.
What Expiration Dates Are on the Recalled PeriGiene Lots?
The recalled PeriGiene lots carry expiration dates from 11/2025 to 1/2027. Lot 31013A expires in 11/2025, and lots 50072A and 50079A expire in 1/2027. Check the label on your bottle or case.
What Does the FDA Warning Letter Say About PeriGiene?
The FDA warning letter quotes the PeriGiene label: “Antiseptic cleanser for use in the perineal area.” These are only the FDA’s own findings about DermaRite. They are not a court ruling.
What Was the Original DermaRite Contact for the PeriGiene Recall?
The original DermaRite contact for the PeriGiene recall was 973-569-9000 x104 and voluntary.action@dermarite.com, from its first notice. The later expansion notice moved questions to Sedgwick at 888-943-5190.