DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination


DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination

NORTH BERGEN, N.J., Aug. 8, 2025 /PRNewswire/ -- DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

Risk Statement: Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis. To date, DermaRite has not received any reports of adverse events related to this recall.

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

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

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.

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

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

Recalled Product Information:

Product Description

Reorder #

Lot

number

Expiration

Date

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30586A

7/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30586B

7/2025

DermaKleen 1000ml. bag-n-box

, 10/case

0092BB

30626A

7/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30628A

8/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30657A

8/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30741A

7/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

30871A

10/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

40002A

12/2025

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

40012A

1/2026

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

40301A

3/2026

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

40789 A

9/2026

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

50068B

1/2027

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

50144A

2/2027

DermaKleen 1000ml. bag-n-box,

10/case

0092BB

50149A

2/2027

DermaKleen 800ml. bag-n-box,

12/case

0090BB

30550A

7/2025

DermaKleen 800ml. bag-n-box,

12/case

0090BB

30670A

8/2025

DermaKleen 800ml. bag-n-box,

12/case

0090BB

30682A

8/2025

DermaKleen 800ml. bag-n-box,

12/case

0090BB

40025A

1/2026

DermaKleen 800ml. bag-n-box,

12/case

0090BB

40375A

4/2026

DermaKleen 800ml. bag-n-box,

12/case

0090BB

40427A

5/2026

DermaKleen 800ml. bag-n-box,

12/case

0090BB

40436A

5/2026

DermaKleen 800ml. bag-n-box,

12/case

0090BB

50068A

1/2027

DermaSarra 7.5oz, 24/case

00188

40187.2

2/2026

KleenFoam 1000ml., 6/case

0093F

30705A

8/2025

KleenFoam 1000ml., 6/case

0093F

30771A

9/2025

KleenFoam 1000ml., 6/case

0093F

30920A

10/2025

KleenFoam 1000ml., 6/case

0093F

40016A

1/2026

KleenFoam 1000ml., 6/case

0093F

40303A

4/2026

KleenFoam 1000ml., 6/case

0093F

40428A

5/2026

KleenFoam 1000ml., 6/case

0093F

40505A

6/2026

KleenFoam 1000ml., 6/case

0093F

41053C

12/2026

KleenFoam 1000ml., 6/case

0093F

41053A

12/2026

KleenFoam 1000ml., 6/case

0093F

41053B

12/2026

KleenFoam 1000ml., 6/case

0093F

50017A

1/2027

PeriGiene 7.5oz., 48/case

00198

31013A

11/2025

PeriGiene 7.5oz., 48/case

00198

40345A

4/2026

PeriGiene 7.5oz., 48/case

00198

40355A

4/2026

PeriGiene 7.5oz., 48/case

00198

40571A

6/2026

PeriGiene 7.5oz., 48/case

00198

40580A

6/2026

PeriGiene 7.5oz., 48/case

00198

40587A

7/2026

PeriGiene 7.5oz., 48/case

00198

40591A

7/2026

PeriGiene 7.5oz., 48/case

00198

40870.1

10/2026

PeriGiene 7.5oz., 48/case

00198

40877.1

10/2026

PeriGiene 7.5oz., 48/case

00198

41093A

12/2026

PeriGiene 7.5oz., 48/case

00198

50072A

1/2027

PeriGiene 7.5oz., 48/case

00198

50079A

1/2027

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 Mary Goldberg at 973-569-9000 x104 Monday through Friday, 9:00 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htmRegular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

View original content to download multimedia:https://www.prnewswire.com/news-releases/dermarite-industries-issues-voluntary-nationwide-recall-of-dermakleen-dermasarra-kleenfoam-and-perigiene-products-due-to-burkholderia-cepacia-contamination-302525623.html

SOURCE DermaRite

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