External analgesic lotion recalled over Burkholderia cepacia contamination
DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, 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
DermaSarra External Analgesic, containing camphor 0.5%, in 222 mL (7.5 fl oz) bottles from DermaRite Industries LLC of North Bergen, New Jersey, NDC 61924-189-08, is being recalled. The affected product is lot 40187.2 with an expiry of 2/2026, and the recall covers 249 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.
Anyone holding this lot should stop using the product and follow the manufacturer's instructions for return or disposal.
The recalled product
- Product
- DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical
- Affected units
- 249
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 (2)
- Lot #: 40187.2
- Exp. Date 2/2026
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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