Class II U.S. Food and Drug Administration

DermaRite Hand Sanitizers, Cleansers, Skin Protectants, Deodorant recall: Device & Drug Safety - Potential Burkholderia cepacian contamination

Recall published 1+ years ago Last updated

Device & Drug Safety - Potential Burkholderia cepacian contamination

DermaRite Prescription & OTC drugs — recalled prescription & otc drugsDermaRite Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)DermaRite Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)DermaRite Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Risk Statement: Burkholderia cepacia complex in these products may result in serious and lifethreatening infections if the products are used by immunosuppressed individuals or by people attending to immunosuppressed individuals.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0160-2026, D-0161-2026, D-0164-2026, D-0166-2026, D-0167-2026, D-0169-2026, D-0170-2026, D-0171-2026
Published
August 8, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
DermaRite
Product type
Prescription & OTC drugs
Units affected
3,178 bottles; 2,673 tubes; 115,994 containers
Distribution
Nationwide
Lot / code info
All lots on or before expiry date 08/2027. — All lots on or before expiry date 08/2027

Products covered by this recall

Hand Sanitizers, Cleansers, Skin Protectants, Deodorant OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers

What the company announced

DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the table below. Please see DermaRite.com for the original recall notice.

Risk Statement: Burkholderia cepacia complex in these products may result in serious and lifethreatening infections if the products are used by immunosuppressed individuals or by people attending to immunosuppressed individuals. For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis.

The products included in this expanded voluntary recall include:

4-N-1 is a no rinse wash cream intended to temporarily protect and help relieve chafed or cracked skin

DermaCerin is a skin protectant moisturizing cream indicated to temporarily protect and help relieve dry, chapped, or cracked skin. It also helps protect skin from the drying effects of wind and cold weather.

DermaFungal is an OTC antifungal cream intended for the treatment and prevention of most athlete’s foot, jock itch, and ringworm. It relieves itching, scaling, cracking, and discomfort associated with these conditions.

DermaKleen is an OTC healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.

DermaMed is an OTC skin protectant intended to dry the oozing and weeping of poison ivy, oak, or sumac, or other skin irritations.

DermaSarra is an OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, or sunburn.

Gel Rite is an OTC instant gel hand sanitizer with vitamin E used to decrease bacteria on the skin. It is recommended for repeated use.

Hand E Foam is an OTC foaming hand sanitizer with vitamin E used for handwashing to decrease bacteria on the skin. It is recommended for repeated use.

KleenFoam is an OTC antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.

Lantiseptic is an OTC skin protectant indicated to temporarily protect minor cuts, scrapes and burns. It helps prevent and temporarily protect chapped or cracked skin.

PeriGiene is an OTC antiseptic cleanser indicated for use in the perineal area.

PeriGuard is an OTC skin protectant indicated to help relieve and prevent rashes and irritation due to wetness from incontinence. It also protects chafed skin due to irritation and helps seal out wetness.

Renew Dimethicone is an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritations associated with diaper rash, and helps seal out wetness.

Renew Periprotect is an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritation associated with diaper rash, and helps seal out wetness.

Renew Skin Repair is an OTC Skin cream indicated to temporarily protect and help relieve chapped or cracked skin. It is beneficial for face, hands, body and legs.

UltraSure is an OTC anti-perspirant & deodorant indicated to reduce underarm wetness.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

Consumers with questions regarding this recall can call Sedgwick at 888-943-5190 Monday through Friday, 8:00 am – 5:00 pm EST or email [email protected] .

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product or have questions about whether the product was used in their health care facility.

See below images for Recalled Product Information List

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. August 8, 2025 — First announcement. DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination Read it on fda.gov
  2. August 27, 2025 — Recall expanded. DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination Read it on fda.gov

Check your product

The notice names 39 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2027
  • 379

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 2027
  • 379

NDC number

On the carton and again on the bottle or blister label.

  • 61924-208-04
  • 61924-174-04
  • 61924-174-16
  • 61924-214-04
  • 61924-106-04
  • 61924-106-16
  • 61924-106-27
  • 61924-106-34
  • 61924-102-08
  • 61924-102-34
  • 61924-504-05
  • 61924-504-04
  • 61924-710-14
  • 61924-304-05
  • 61924-304-14
  • 61924-304-04
  • 61924-304-45
  • 61924-304-12
  • 68599-6202-1
  • 68599-6203-4

Package size

Match the net weight or the piece count on the front of the pack.

  • 4 oz
  • 3.75 oz
  • 16 oz
  • 118 mL
  • 473 mL
  • 800 mL
  • 1000 mL
  • 236 mL
  • 0.17 oz
  • 14 oz
  • 0.5 oz
  • 4.5 oz
  • 12 oz
  • 4 fl. oz

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

DermaRite — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Remedy named in the notice: DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

Company contact: DermaRite Industries — Consumers: Sedgwick, 888-943-5190, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was DermaRite prescription & otc drugs recalled?

Device & Drug Safety - Potential Burkholderia cepacian contamination Risk Statement: Burkholderia cepacia complex in these products may result in serious and lifethreatening infections if the products are used by immunosuppressed individuals or by people attending to immunosuppressed individuals.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2027, 379; best-by date 08 or 2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

Where was the recalled product sold?

It was distributed nationwide.

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