FDA Recall Alert – Soap Recall Expands to Hand Sanitizer, Deodorant, and More Over Sepsis Concerns

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DermaRite Industries has expanded its previously announced hand soap recall to include a wide range of additional products such as hand sanitizer, deodorant, body wash, and lotions. This expanded recall is being carried out with support from the U.S. Food and Drug Administration (FDA), following concerns that several products may be contaminated with Burkholderia cepacia, a group of bacteria that can cause serious infections in vulnerable individuals.

If you’ve used or stock any of DermaRite’s hygiene or skincare products, here’s everything you need to know.

Contamination

At the heart of the recall is Burkholderia cepacia, a type of bacteria often found in soil and water. According to the CDC, while it generally poses low risk to healthy individuals, it can be dangerous for those with weakened immune systems or chronic lung conditions like cystic fibrosis. Infections can range from mild to severe and may lead to respiratory illness or even sepsis in serious cases.

Using contaminated products on broken or irritated skin increases the risk of infection, especially for immunocompromised users.

Products

The recall now includes dozens of DermaRite products used in both clinical and personal settings. These range from no-rinse cleansers and antifungal creams to hand sanitizers and body lotions. Below are some of the key products involved in the expanded recall:

Product NameDescription
4-N-1No-rinse wash cream for cracked skin
Clean-N-FreeRinse-free body wash and perineal cleanser
DermaCerinMoisturizing cream for dry, chapped skin
DemaDailySoothing lotion for sensitive skin
DermaFungalAntifungal cream for jock itch and ringworm
DermaKleenAntiseptic lotion soap with Vitamin E
DemaKlenzWound cleanser, odor-reducing, no rinse needed
DermaMedTreats poison ivy and similar irritations
DermaRainMild, pH-balanced body wash and shampoo
DermaSarraExternal analgesic for minor skin irritations
DermaSynHydrogel wound dressing
DermaVantageMoisturizing lotion
DermaVeraFull-body cleanser with shea butter
Gel RiteInstant gel hand sanitizer with Vitamin E
Hand E FoamFoaming hand sanitizer with Vitamin E
KleenFoamAntimicrobial foam soap with aloe vera
LantisepticSkin protectant for cuts and scrapes
LubriSilkLotion for dry, rough skin
PeriFreshSpray cleanser for incontinence care
PeriGieneAntiseptic perineal cleanser
PeriGuardRash prevention and relief from wetness
Renew Hair & Body WashVitamin-rich body and hair cleanser
Renew DimethiconeTreats and prevents diaper rash
Renew Full Body WashFor hands, body, hair, and perineal care
Renew PeriprotectSkin protectant for diaper rash
Renew Skin RepairCream for chapped or cracked skin
San-E-FoamFoaming hand sanitizer with Vitamin E
TotalBathVitamin E enriched body wash and shampoo
TotalFoamMild body wash for all-over use
UltraSureAntiperspirant and deodorant
WhirlBathGentle cleanser for whirlpool or tub use

DermaRite’s website and recall notice include specific identification details such as product numbers, lot codes, and expiration dates.

Symptoms

Symptoms from exposure can range from minor irritation to more serious respiratory infections. People with compromised immune systems, especially those with lung conditions, should be particularly cautious. Common symptoms may include:

  • Fever
  • Fatigue
  • Shortness of breath
  • Skin irritation or infection at the application site

The bacteria’s resistance to antibiotics also makes treatment more complicated if an infection develops.

Action

DermaRite has instructed all distributors and customers to immediately inspect and dispose of any affected inventory following their facility’s procedures. Consumers who may have used a recalled product and feel unwell should contact a healthcare provider as soon as possible.

For any questions or concerns, you can:

  • Call Sedgwick at 888-943-5190 (Monday–Friday, 8 a.m. to 5 p.m. EST)
  • Email: [email protected]

Risk

The good news is that for most healthy individuals, the risk remains low. However, facilities like hospitals and nursing homes, which use these products with at-risk populations, must take immediate action to prevent any chance of infection.

Make sure to check your product labels and lot numbers, and if you’re unsure, reach out to DermaRite or your local healthcare provider for further guidance.

FAQs

Why were DermaRite products recalled?

Due to possible contamination with Burkholderia cepacia bacteria.

What symptoms can the bacteria cause?

Symptoms include fatigue, fever, and respiratory issues.

Are all DermaRite products affected?

No, only certain products listed in the recall are affected.

How should recalled items be handled?

Destroy affected products as per facility procedures.

Who should I contact about the recall?

Call 888-943-5190 or email [email protected].

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