Health care antiseptic recalled over contamination with Burkholderia cepacia bacteria
DermaRite PeriGiene Health Care Antiseptic containing chloroxylenol 0.5% is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this Burkholderia cepacia contamination as Class I.
Plain-English summary
PeriGiene Health Care Antiseptic, containing chloroxylenol 0.5%, in 222 mL (7.5 fl oz) bottles from DermaRite Industries LLC of North Bergen, New Jersey, NDC 61924-198-08, is being recalled. Affected lots include 31013A expiring 11/2025, 40345A and 40355A expiring 4/2026, and 40571A, 40580A and 40587A expiring 6/2026, with the full list in the recall notice. The recall covers 5,703 bottles distributed nationwide.
The recall was issued for microbial contamination of a non-sterile drug product: the products were found to be contaminated with the bacteria Burkholderia cepacia. The FDA classified the action as Class I, its most serious category.
Healthcare facilities and consumers holding these lots should stop using the product and follow the manufacturer's instructions for return or disposal.
The recalled product
- Product
- PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Antiseptic
- Affected units
- 5,703
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 (19)
- Lot #: 31013A
- Exp. Date 11/2025
- 40345A
- 40355A
- Exp. Date 4/2026
- 40571A
- 40580A
- Exp. Date 6/2026
- 40587A
- 40591A
- Exp. Date 7/2026
- 40870.1
- 40877.1
- Exp. Date 10/2026
- 41093A
- Exp. Date 12/2026
- 50072A
- 50079A
- Exp. Date 1/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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