Antiseptic lotion soap recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 7,736 tubes of DermaKleen antiseptic lotion soap because it was made at the same facility where other products were found contaminated.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary recall: the record cites contamination found elsewhere in the facility rather than confirmed contamination of these lots or any reported harm.
Plain-English summary
DermaKleen Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, in 222 mL tubes, 800 mL bags and 1000 mL bags (NDCs 61924-092-08, -27 and -34), from DermaRite Industries of North Bergen, New Jersey, is being recalled for a CGMP deviation.
The recall follows the product being manufactured at the same facility where other products and lots were found to be contaminated.
The recall covers 7,736 tubes across all lots with an expiry date on or before August 2027. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record cites facility association rather than confirmed contamination of these lots, and reports no illnesses. Facilities holding affected product should follow the firm's instructions.
The recalled product
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC…
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Antiseptic
- Affected units
- 7,736
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by DermaRite Industries, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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