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.
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SOURCE DermaRite